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1.
JAMA ; 331(8): 654-664, 2024 02 27.
Article in English | MEDLINE | ID: mdl-38411644

ABSTRACT

Importance: Randomized clinical trials of bariatric surgery have been limited in size, type of surgical procedure, and follow-up duration. Objective: To determine long-term glycemic control and safety of bariatric surgery compared with medical/lifestyle management of type 2 diabetes. Design, Setting, and Participants: ARMMS-T2D (Alliance of Randomized Trials of Medicine vs Metabolic Surgery in Type 2 Diabetes) is a pooled analysis from 4 US single-center randomized trials conducted between May 2007 and August 2013, with observational follow-up through July 2022. Intervention: Participants were originally randomized to undergo either medical/lifestyle management or 1 of the following 3 bariatric surgical procedures: Roux-en-Y gastric bypass, sleeve gastrectomy, or adjustable gastric banding. Main Outcome and Measures: The primary outcome was change in hemoglobin A1c (HbA1c) from baseline to 7 years for all participants. Data are reported for up to 12 years. Results: A total of 262 of 305 eligible participants (86%) enrolled in long-term follow-up for this pooled analysis. The mean (SD) age of participants was 49.9 (8.3) years, mean (SD) body mass index was 36.4 (3.5), 68.3% were women, 31% were Black, and 67.2% were White. During follow-up, 25% of participants randomized to undergo medical/lifestyle management underwent bariatric surgery. The median follow-up was 11 years. At 7 years, HbA1c decreased by 0.2% (95% CI, -0.5% to 0.2%), from a baseline of 8.2%, in the medical/lifestyle group and by 1.6% (95% CI, -1.8% to -1.3%), from a baseline of 8.7%, in the bariatric surgery group. The between-group difference was -1.4% (95% CI, -1.8% to -1.0%; P < .001) at 7 years and -1.1% (95% CI, -1.7% to -0.5%; P = .002) at 12 years. Fewer antidiabetes medications were used in the bariatric surgery group. Diabetes remission was greater after bariatric surgery (6.2% in the medical/lifestyle group vs 18.2% in the bariatric surgery group; P = .02) at 7 years and at 12 years (0.0% in the medical/lifestyle group vs 12.7% in the bariatric surgery group; P < .001). There were 4 deaths (2.2%), 2 in each group, and no differences in major cardiovascular adverse events. Anemia, fractures, and gastrointestinal adverse events were more common after bariatric surgery. Conclusion and Relevance: After 7 to 12 years of follow-up, individuals originally randomized to undergo bariatric surgery compared with medical/lifestyle intervention had superior glycemic control with less diabetes medication use and higher rates of diabetes remission. Trial Registration: ClinicalTrials.gov Identifier: NCT02328599.


Subject(s)
Bariatric Surgery , Diabetes Mellitus, Type 2 , Gastric Bypass , Adult , Female , Humans , Male , Middle Aged , Bariatric Surgery/adverse effects , Body Mass Index , Diabetes Mellitus, Type 2/complications , Diabetes Mellitus, Type 2/surgery , Diabetes Mellitus, Type 2/therapy , Follow-Up Studies , Glycated Hemoglobin , Randomized Controlled Trials as Topic , Treatment Outcome
2.
Ann Surg ; 278(3): e519-e525, 2023 09 01.
Article in English | MEDLINE | ID: mdl-36538630

ABSTRACT

OBJECTIVE: To describe alcohol use, alcohol-related harm, and alcohol-related problems preoperatively and up to 8 years following metabolic and bariatric surgery (MBS) in adolescents. BACKGROUND: Risk for alcohol use and alcohol use disorders (AUD) increases post-Roux-en-Y gastric bypass and vertical sleeve gastrectomy in adults. However, data are lacking in adolescents who undergo MBS. METHODS: This study includes 217 adolescents (aged 13-19 y) enrolled in a 5-center prospective cohort study who underwent Roux-en-Y gastric bypass or vertical sleeve gastrectomy (2007-2011) and reported alcohol use preoperatively and annually postoperatively for up to 8 years. Time to elevated Alcohol Use Disorder Identification Test-Consumption (AUDIT-C) score, alcohol-related harm, and alcohol-related problems were analyzed with Kaplan-Meier estimates of cumulative incidence. RESULTS: Preoperatively, the median age was 17 years; the median body mass index was 51 kg/m 2 . Alcohol use frequency and average quantity of drinks per drinking day increased postoperatively (2% consumed alcohol 2-4 times/month 6 months versus 24% 8 years postoperatively, P <0.001; 2% consumed≥3 drinks per drinking day 6 months versus 35% 8 years postoperatively, P <0.001). Cumulative incidence of postoperative onset elevated AUDIT-C score, alcohol-related harm, and alcohol-related problems at year 8 were 45% (95% CI:37-53), 43% (95% CI:36-51), and 47% (95% CI:40-55), respectively. CONCLUSIONS: Nearly half of those who underwent MBS as adolescents screened positively for AUD, symptoms of alcohol-related harm, or alcohol-related problems 8 years post-MBS, highlighting the risk for alcohol use and AUD after MBS in adolescents. AUD evaluation and treatment should be integrated into routine long-term care for adolescents undergoing MBS.


Subject(s)
Alcohol-Related Disorders , Alcoholism , Bariatric Surgery , Gastric Bypass , Obesity, Morbid , Adult , Humans , Adolescent , Obesity, Morbid/surgery , Prospective Studies , Alcoholism/epidemiology , Alcoholism/etiology , Alcoholism/surgery , Bariatric Surgery/adverse effects , Gastric Bypass/adverse effects , Gastrectomy/adverse effects
3.
Ann Surg ; 277(3): 442-448, 2023 03 01.
Article in English | MEDLINE | ID: mdl-34387200

ABSTRACT

OBJECTIVE: To separately compare the long-term risk of mortality among bariatric surgical patients undergoing either Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) to large, matched, population-based cohorts of patients with severe obesity who did not undergo surgery. BACKGROUND: Bariatric surgery has been associated with reduced long-term mortality compared to usual care for severe obesity which is particularly relevant in the COVID-19 era. Most prior studies involved the RYGB operation and there is less long-term data on the SG. METHODS: In this retrospective, matched cohort study, patients with a body mass index ≥35 kg/m 2 who underwent bariatric surgery from January 2005 to September 2015 in three integrated health systems in the United States were matched to nonsurgical patients on site, age, sex, body mass index, diabetes status, insulin use, race/ethnicity, combined Charlson/Elixhauser comorbidity score, and prior health care utilization, with follow-up through September 2015. Each procedure (RYGB, SG) was compared to its own control group and the two surgical procedures were not directly compared to each other. Multivariable-adjusted Cox regression analysis investigated time to all-cause mortality (primary outcome) comparing each of the bariatric procedures to usual care. Secondary outcomes separately examined the incidence of cardiovascular-related death, cancer related-death, and diabetes related-death. RESULTS: Among 13,900 SG, 17,258 RYGB, and 87,965 nonsurgical patients, the 5-year follow-up rate was 70.9%, 72.0%, and 64.5%, respectively. RYGB and SG were each associated with a significantly lower risk of all-cause mortality compared to nonsurgical patients at 5-years of follow-up (RYGB: HR = 0.43; 95% CI: 0.35,0.54; SG: HR = 0.28; 95% CI: 0.13,0.57) Similarly, RYGB was associated with a significantly lower 5-year risk of cardiovascular-(HR = 0.27; 95% CI: 0.20, 0.37), cancer- (HR = 0.54; 95% CI: 0.39, 0.76), and diabetes-related mortality (HR = 0.23; 95% CI:0.15, 0.36). There was not enough follow-up time to assess 5-year cause-specific mortality in SG patients, but at 3-years follow-up, there was significantly lower risk of cardiovascular- (HR = 0.33; 95% CI:0.19, 0.58), cancer- (HR = 0.26; 95% CI:0.11, 0.59), and diabetes-related (HR = 0.15; 95% CI:0.04, 0.53) mortality for SG patients. CONCLUSION: This study confirms and extends prior findings of an association with better survival following bariatric surgery in RYGB patients compared to controls and separately demonstrates that the SG operation also appears to be associated with lower mortality compared to matched control patients with severe obesity that received usual care. These results help to inform the tradeoffs between long-term benefits and risks of bariatric surgery.


Subject(s)
COVID-19 , Gastric Bypass , Obesity, Morbid , Humans , Obesity, Morbid/surgery , Cohort Studies , Retrospective Studies , Gastrectomy
4.
Ann Surg ; 276(5): e425-e433, 2022 11 01.
Article in English | MEDLINE | ID: mdl-33234799

ABSTRACT

OBJECTIVE: The aim of this study was to examine change in overall satisfaction with Roux-en-Y gastric bypass (RYGB) surgery over 3 to 7 years post-surgery and identify pre-surgery predictors and post-surgery factors associated with not being satisfied. BACKGROUND: It is unclear how satisfaction with RYGB surgery changes over time following surgery and factors associated with not being satisfied are not well understood. METHODS: Participants of a multicenter prospective cohort study of bariatric surgery were followed annually < 7 years. A total of 1423 participants of the 1770 who underwent RYGB had data on satisfaction with surgery (81% female; median age 47 years; median body mass index 46 kg/m 2 ). RESULTS: The percentage of participants who were not satisfied with RYGB surgery significantly increased from 15.4% 3 years post-surgery to 23.0% 7 years post-surgery ( P = 0.01). Pre-surgery younger age, lower BMI, higher percent weight loss needed to reach dream weight, poorer physical and mental health, and less social support independently predicted higher risk of not being satisfied with surgery. When examining pre- to post-surgery changes, less post-surgery weight loss, worsening physical and mental health status, less social support, and greater depressive symptomology were associated with higher risk of not being satisfied with surgery. CONCLUSIONS: Level of satisfaction with RYGB surgery significantly decreased 3 to 7 years following surgery. Several pre- and post-surgery characteristics were associated with not being satisfied with surgery and provide potentially useful insight into individual patient experiences following RYGB. Knowledge of these characteristics may be useful in communication between surgeons and patients regarding post-surgical expectations and the impact of surgery on patients' lives.


Subject(s)
Gastric Bypass , Obesity, Morbid , Body Mass Index , Female , Gastric Bypass/methods , Humans , Male , Middle Aged , Obesity, Morbid/surgery , Personal Satisfaction , Prospective Studies , Weight Loss
5.
Ann Surg ; 276(6): e777-e783, 2022 12 01.
Article in English | MEDLINE | ID: mdl-33234795

ABSTRACT

OBJECTIVE: To examine associations of objectively-measured free-living physical activity (PA) with changes in depressive symptoms and mental and physical health-related quality of life (HRQoL) over 7 years after Roux-en-Y gastric bypass surgery (RYGB). BACKGROUND: The contributions of PA to improvements in mental and physical health after RYGB, independent of weight loss, are unclear. METHODS: Adults undergoing RYGB in a US multi-center cohort study wore an activity monitor and completed the Beck depression inventory (BDI) and 36-Item Short Form Health Survey (SF-36) annually ≤7 years (N = 646; 78% female, median age 47 years, median body mass index 46kg/m 2 ). Linear mixed models estimated associations of quartiles of steps, sedentary behavior (SB), and moderate-to-vigorous intensity physical activity (MVPA), respectively, with pre-to-post-surgery changes in the BDI and SF-36 mental component summary and physical component summary scores, respectively, over 1-7 years post-surgery, with adjustment for sex, age, race, pre-surgerybody mass index, the respective pre-surgery score, treatment for depression (time-varying) and pre-to-post-surgery weight change (time-varying). RESULTS: There were dose-response associations between steps, SB (inverse) and MVPA quartiles, respectively, with improvements in each score. Across follow-up, mean improvements in the BDI, Mental Component Summary and physical component summary scores, were 1.9 [95% confidence interval (CI), 1.0-2.8], 3.1 (95% CI, 1.5-4.7), and 4.0 (95% CI, 2.7-5.4) points higher, respectively, in the highest versus lowest steps quartile. CONCLUSION: Among adults who underwent RYGB, multiple objective PA measures were associated with decreases in depressive symptoms and improvements in mental and physical HRQoL throughout 7 years, independent of weight loss, indicating PA is a modifiable behavior to augment outcomes.


Subject(s)
Gastric Bypass , Obesity, Morbid , Adult , Female , Humans , Middle Aged , Male , Quality of Life , Depression/etiology , Obesity, Morbid/surgery , Cohort Studies , Prospective Studies , Exercise/physiology , Weight Loss/physiology
6.
Ann Surg ; 275(4): 718-726, 2022 04 01.
Article in English | MEDLINE | ID: mdl-32889873

ABSTRACT

OBJECTIVE: To examine associations of objectively-measured physical activity (PA) with changes in weight after roux-en-Y gastric bypass (RYGB) over 7 years. BACKGROUND: The contribution of free-living PA to surgery-induced weight loss and subsequent weight regain is not well understood. METHODS: Participants of a multi-center prospective cohort study of bariatric surgery were followed annually ≥7 years. Of 807 participants who underwent RYGB and were given an activity monitor, 649 (80%) had sufficient data for this report (78% female; median age 47 years; median body mass index 46 kg/m2). Mean daily steps, hours/day in SB and minutes/week in moderate-to-vigorous physical activity (MVPA) were determined at each assessment. Mixed models tested associations between PA measures and weight outcomes, controlling for sociodemographics, health status, and eating behaviors. RESULTS: Across follow-up, mean pre to postsurgery changes in PA were small, and mean postsurgery PA level was below PA recommendations for health (eg, 101 MVPA min/week 7 years postsurgery versus the ≥150 MVPA min/week recommendation). There was a dose-response association between more steps, less SB and more MVPA with greater weight loss. Steps and SB, but not MVPA, were also associated with weight regain. For example, participants in the highest versus lowest steps quartile lost 2.9% (95% confidence interval, 1.8-4.1) more of their presurgery weight and regained 5.4% (95% confidence interval, 2.4-8.3) less of their maximum weight lost across follow-up. CONCLUSIONS: Despite only small increases in objectively-measured PA level after RYGB, PA level was independently associated with weight outcomes of bariatric surgery throughout 7 years of follow-up. REPRINTS: Reprints will not be available from the authors.


Subject(s)
Gastric Bypass , Obesity, Morbid , Body Mass Index , Exercise , Female , Humans , Male , Middle Aged , Obesity, Morbid/surgery , Prospective Studies , Weight Gain , Weight Loss/physiology
7.
Ann Surg ; 275(1): 131-139, 2022 01 01.
Article in English | MEDLINE | ID: mdl-32084036

ABSTRACT

OBJECTIVE: To evaluate smoking history and change in smoking behavior, from 1 year before through 7 years after Roux-en-Y gastric bypass (RYGB) surgery, and to identify risk factors for post-surgery smoking. BACKGROUND: Smoking behavior in the context of bariatric surgery is poorly described. METHODS: Adults undergoing RYGB surgery entered a prospective cohort study between 2006 and 2009 and were followed up to 7 years until ≤2015. Participants (N = 1770; 80% female, median age 45 years, median body mass index 47 kg/m2) self-reported smoking history pre-surgery, and current smoking behavior annually. RESULTS: Almost half of participants (45.2%) reported a pre-surgery history of smoking. Modeled prevalence of current smoking decreased in the year before surgery from 13.7% [95% confidence interval (CI) = 12.1-15.4] to 2.2% (95% CI = 1.5-2.9) at surgery, then increased to 9.6% (95% CI = 8.1-11.2) 1-year post-surgery and continued to increase to 14.0% (95% CI = 11.8-16.0) 7-years post-surgery. Among smokers, mean packs/day was 0.60 (95% CI = 0.44-0.77) at surgery, 0.70 (95% CI = 0.62-0.78) 1-year post-surgery and 0.77 (95% CI = 0.68-0.88) 7-years post-surgery. At 7-years, smoking was reported by 61.7% (95% CI = 51.9-70.8) of participants who smoked 1-year pre-surgery (n = 221), 12.3% (95% CI = 8.5-15.7) of participants who formerly smoked but quit >1 year pre-surgery (n = 507), and 3.8% (95% CI = 2.1-4.9) of participants who reported no smoking history (n = 887). Along with smoking history (ie, less time since smoked), younger age, household income <$25,000, being married or living as married, and illicit drug use were independently associated with increased risk of post-surgery smoking. CONCLUSION: Although most adults who smoked 1-year before RYGB quit pre-surgery, smoking prevalence rebounded across 7-years, primarily due to relapse.


Subject(s)
Gastric Bypass/psychology , Smoking/epidemiology , Adult , Body Mass Index , Female , Follow-Up Studies , Humans , Male , Middle Aged , Obesity, Morbid/psychology , Obesity, Morbid/surgery , Prevalence , Prospective Studies , Risk Factors , Self Report , Smoking Cessation
8.
Ann Surg ; 276(6): e784-e791, 2022 12 01.
Article in English | MEDLINE | ID: mdl-33914480

ABSTRACT

OBJECTIVE: A retrospective cohort study investigated the association between having surgery and risk of mortality for up to 5 years and if this association was modified by incident ESRD during the follow-up period. Summary of Background Data: Mortality risk in individuals with pre-dialysis CKD is high and few effective treatment options are available. Whether bariatric surgery can improve survival in people with CKD is unclear. METHODS: Patients with class II and III obesity and pre-dialysis CKD stages 3-5 who underwent bariatric surgery between January 1, 2006 and September 30, 2015 (n = 802) were matched to patients who did not have surgery (n = 4933). Mortality was obtained from state death records and ESRD was identified through state-based or healthcare system-based registries. Cox regression models were used to investigate the association between bariatric surgery and risk of mortality and if this was moderated by incident ESRD during the follow-up period. RESULTS: Patients were primarily women (79%), non-Hispanic White (72%), under 65 years old (64%), who had a body mass index > 40kg/m 2 (59%), diabetes (67%), and hypertension (89%). After adjusting for incident ESRD, bariatric surgery was associated with a 79% lower 5-year risk of mortality compared to matched controls (hazard ratio = 0.21; 95% confidence interval: 0.14-0.32; P < 0.001). Incident ESRD did not moderate the observed association between surgery and mortality (hazard ratio = 1.59; 95% confidence interval: 0.31-8.23; P =0.58). CONCLUSIONS: Bariatric surgery is associated with a reduction in mortality in pre-dialysis patients regardless of developing ESRD. These findings are significant because patients with CKD are at relatively high risk for death with few efficacious interventions available to improve survival.


Subject(s)
Bariatric Surgery , Kidney Failure, Chronic , Renal Insufficiency, Chronic , Humans , Female , Aged , Kidney Failure, Chronic/complications , Kidney Failure, Chronic/surgery , Retrospective Studies , Renal Insufficiency, Chronic/complications , Renal Insufficiency, Chronic/surgery , Bariatric Surgery/adverse effects , Proportional Hazards Models
9.
N Engl J Med ; 380(22): 2136-2145, 2019 05 30.
Article in English | MEDLINE | ID: mdl-31116917

ABSTRACT

BACKGROUND: Bariatric surgery results in weight loss and health improvements in adults and adolescents. However, whether outcomes differ according to the age of the patient at the time of surgery is unclear. METHODS: We evaluated the health effects of Roux-en-Y gastric bypass in a cohort of adolescents (161 patients enrolled from 2006 through 2012) and a cohort of adults (396 patients enrolled from 2006 through 2009). The two cohorts were participants in two related but independent studies. Linear mixed and Poisson mixed models were used to compare outcomes with regard to weight and coexisting conditions between the cohorts 5 years after surgery. The rates of death and subsequent abdominal operations and selected micronutrient levels (up to 2 years after surgery) were also compared between the cohorts. RESULTS: There was no significant difference in percent weight change between adolescents (-26%; 95% confidence interval [CI], -29 to -23) and adults (-29%; 95% CI, -31 to -27) 5 years after surgery (P = 0.08). After surgery, adolescents were significantly more likely than adults to have remission of type 2 diabetes (86% vs. 53%; risk ratio, 1.27; 95% CI, 1.03 to 1.57) and of hypertension (68% vs. 41%; risk ratio, 1.51; 95% CI, 1.21 to 1.88). Three adolescents (1.9%) and seven adults (1.8%) died in the 5 years after surgery. The rate of abdominal reoperations was significantly higher among adolescents than among adults (19 vs. 10 reoperations per 500 person-years, P = 0.003). More adolescents than adults had low ferritin levels (72 of 132 patients [48%] vs. 54 of 179 patients [29%], P = 0.004). CONCLUSIONS: Adolescents and adults who underwent gastric bypass had marked weight loss that was similar in magnitude 5 years after surgery. Adolescents had remission of diabetes and hypertension more often than adults. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases; ClinicalTrials.gov number, NCT00474318.).


Subject(s)
Gastric Bypass , Obesity, Morbid/surgery , Weight Loss , Adolescent , Adult , Age Factors , Body Mass Index , Cohort Studies , Diabetes Mellitus, Type 2/complications , Female , Ferritins/blood , Gastric Bypass/mortality , Glycated Hemoglobin/analysis , Humans , Hypertension/complications , Linear Models , Male , Middle Aged , Obesity, Morbid/blood , Obesity, Morbid/complications , Obesity, Morbid/mortality , Poisson Distribution , Remission Induction , Reoperation/statistics & numerical data , Vitamin D/analogs & derivatives , Vitamin D/blood , Young Adult
10.
Diabetes Obes Metab ; 24(7): 1206-1215, 2022 07.
Article in English | MEDLINE | ID: mdl-35233923

ABSTRACT

AIMS: Long-term data from randomized clinical trials comparing metabolic (bariatric) surgery versus a medical/lifestyle intervention for treatment of patients with obesity/overweight and type 2 diabetes (T2D) are lacking. The Alliance of Randomized Trials of Medicine vs Metabolic Surgery in Type 2 Diabetes (ARMMS-T2D) is a consortium of four randomized trials designed to compare long-term efficacy and safety of surgery versus medical/lifestyle therapy on diabetes control and clinical outcomes. MATERIALS AND METHODS: Patients with T2D and body mass index (BMI) of 27-45 kg/m2 who were previously randomized to metabolic surgery (Roux-en-Y gastric bypass, adjustable gastric band, or sleeve gastrectomy) versus medical/lifestyle intervention in the STAMPEDE, SLIMM-T2D, TRIABETES, or CROSSROADS trials have been enrolled in ARMMS-T2D for observational follow-up. The primary outcome is change in glycated haemoglobin after a minimum 7 years of follow-up, with additional analyses to determine rates of diabetes remission and relapse, as well as cardiovascular and renal endpoints. RESULTS: In total, 302 patients (192 surgical, 110 medical/lifestyle) previously randomized in the four parent studies were eligible for participation in the ARMMS-T2D observational study. Participant demographics were 71% white, 27% African-American and 68% female. At baseline: age, 50 ± 8 years; BMI, 36.5 ± 3.5 kg/m2 ; duration of diabetes, 8.8 ± 5.6 years; glycated haemoglobin, 8.6% ± 1.6%; and fasting glucose, 168 ± 64 mg/dl. More than 35% of patients had a BMI <35 kg/m2 . CONCLUSIONS: ARMMS-T2D will provide the largest body of long-term, level 1 evidence to inform clinical decision-making regarding the comparative durability, efficacy and safety of metabolic surgery relative to a medical/lifestyle intervention among patients with T2D, including those with milder class I obesity or mere overweight.


Subject(s)
Bariatric Surgery , Diabetes Mellitus, Type 2 , Gastric Bypass , Obesity, Morbid , Adult , Diabetes Mellitus, Type 2/complications , Diabetes Mellitus, Type 2/surgery , Female , Gastrectomy/methods , Gastric Bypass/methods , Glycated Hemoglobin/metabolism , Humans , Male , Middle Aged , Obesity/surgery , Obesity, Morbid/surgery , Overweight/complications , Overweight/therapy , Randomized Controlled Trials as Topic , Treatment Outcome
11.
Ann Surg ; 274(6): e1269-e1276, 2021 12 01.
Article in English | MEDLINE | ID: mdl-32187033

ABSTRACT

OBJECTIVE: To investigate weight trajectories among patients with severe obesity undergoing sleeve gastrectomy (SG), Roux-en-Y gastric bypass (RYGB), and nonsurgical treatment. BACKGROUND: Although bariatric procedures are associated with substantial weight loss, few studies have compared surgical outcomes to nonsurgical treatment, particularly for SG. METHODS: In this retrospective, matched cohort study, adult patients with body mass index ≥35 kg/m2 who underwent RYGB or SG procedures from January 2005 through September 2015 were matched to 87,965 nonsurgical patients. Hierarchical linear models were used to investigate percent total weight loss (%TWL) and regain at 5 years among RYGB, SG, and nonsurgical patients, and at 10 years for RYGB and nonsurgical patients. RESULTS: Among 13,900 SG, 17,258 RYGB, and 87,965 nonsurgical patients, the 5-year follow-up rate was 70.9%, 72.0%, and 64.5%, respectively. At 1 year, RYGB patients had 28.4%TWL (95% confidence interval: 28.2, 28.5), SG 23.0%TWL (22.8, 23.2), and nonsurgical patients 0.2%TWL (0.1, 0.4). At 5 years, RYGB had 21.7%TWL (21.5, 22.0), SG 16.0%TWL (15.4, 16.6), and nonsurgical patients 2.2%TWL (2.0, 2.5). After 5 years, 3.7% of RYGB and 10.1% of SG patients had regained weight to within 5% of baseline. At 10 years, RYGB patients had 20.2%TWL (19.3, 21.0) and nonsurgical patients 4.8%TWL (4.0, 5.5). CONCLUSIONS: In this study, patients with severe obesity who underwent SG and RYGB lost significantly more weight at 5 years than nonsurgical patients. Weight regain was common after surgery but regain to within 5% of baseline was rare.


Subject(s)
Gastrectomy , Gastric Bypass , Obesity, Morbid/surgery , Weight Loss , Adult , Aged , California/epidemiology , Conservative Treatment , Female , Gastrectomy/methods , Gastrectomy/statistics & numerical data , Gastric Bypass/methods , Gastric Bypass/statistics & numerical data , Humans , Male , Middle Aged , Obesity, Morbid/epidemiology , Registries/statistics & numerical data , Retrospective Studies , Treatment Outcome , Young Adult
12.
Ann Surg ; 273(4): 758-765, 2021 04 01.
Article in English | MEDLINE | ID: mdl-31188199

ABSTRACT

OBJECTIVE: To compare the long-term risks of reintervention following sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) in a large surgical cohort. BACKGROUND: The use of SG has increased dramatically relative to RYGB for the treatment of obesity. However, long-term risks following SG compared with RYGB have not been adequately defined in a large population-based study. METHODS: A retrospective longitudinal cohort study of all adult health-plan members undergoing SG or RYGB for obesity in a multistate integrated health care system from January 2005 through September 2015. The risks of nutritional, endoscopic, radiologic, and surgical reintervention as well as the overall risk of any reinterventions at 1, 3, and 5 years were identified using diagnosis and procedure codes from comprehensive electronic medical records. RESULTS: The study included 15,319 patients who underwent SG and 19,954 patients who underwent RYGB with a follow-up of 79.2%. The overall risk of any reintervention at 5 years was 21.3% for SG and 28.3% for RYGB (P < 0.0001). After adjustment, SG was associated with fewer reinterventions through 5 years than RYGB (hazard ratio, 0.78; 95% confidence interval, 0.74-0.84). When comparing subcategories, SG also had a lower risk of nutritional, endoscopic, radiologic, and surgical reinterventions when examined versus RYGB. The findings for risks of reinterventions were consistent across clinical subgroups. CONCLUSION: SG has significantly lower risk of reintervention in all categories studied when compared with RYGB at 5-year follow-up. The long-term safety profile of LSG compared with RYGB should be an essential part of the discussion in patient-centered decision making when choosing between bariatric procedure options.


Subject(s)
Gastrectomy/methods , Gastric Bypass/methods , Obesity, Morbid/surgery , Reoperation/statistics & numerical data , Weight Loss/physiology , Adult , Aged , Follow-Up Studies , Humans , Middle Aged , Retrospective Studies , Time Factors , Treatment Outcome , Young Adult
13.
Ann Surg ; 272(6): 1044-1052, 2020 12.
Article in English | MEDLINE | ID: mdl-30950861

ABSTRACT

OBJECTIVE: To identify patient behaviors and characteristics related to weight regain after Roux-en-Y gastric bypass surgery (RYGB). BACKGROUND: There is considerable variation in the magnitude of weight regain after RYGB, highlighting the importance of patient-level factors. METHODS: A prospective cohort study of adults who underwent bariatric surgery in 6 US cities between 2006 and 2009 included presurgery, and 6-month and annual assessments for up to 7 years. Of 1573 eligible participants, 1278 (81%) with adequate follow-up were included (80% female, median age 46 years, median body mass index 46 kg/m). Percentage of maximum weight lost was calculated each year after weight nadir. RESULTS: Weight was measured a median of 8 (25th-75th percentile, 7-8) times over a median of 6.6 (25th-75th percentile, 5.9-7.0) years. ß coefficients, that is, the mean weight regain, compared with the reference, and 95% confidence interval, are reported. Postsurgery behaviors independently associated with weight regain were: sedentary time [2.9% (1.2-4.7), for highest vs lowest quartile], eating fast food [0.5% (0.2-0.7) per meal/wk], eating when feeling full [2.9% (1.2-4.5)], eating continuously [1.6% (0.1-3.1)], binge eating and loss-of-control eating [8.0% (5.1-11.0) for binge eating; 1.6 (-0.1 to 3.3) for loss of control, vs neither], and weighing oneself

Subject(s)
Gastric Bypass , Health Behavior , Weight Gain , Adult , Aged , Cohort Studies , Female , Humans , Male , Middle Aged , Prospective Studies , Time Factors , Young Adult
14.
Clin Gastroenterol Hepatol ; 18(5): 1070-1081.e5, 2020 05.
Article in English | MEDLINE | ID: mdl-31706057

ABSTRACT

BACKGROUND & AIMS: Little is known about prevalence and risk factors for nutritional deficiencies in adolescents after metabolic bariatric surgery. We performed a 5-year prospective cohort study of these. METHODS: Adolescents who had Roux-en-Y gastric bypass (RYGB, n = 161) or vertical sleeve gastrectomy (VSG, n = 67) were enrolled at 5 tertiary-care centers from March 2007 through February 2012. The final analysis cohort included 226 participants (161 who had RYGB and 65 who had VSG). We measured serum levels of ferritin; red blood cell folate; vitamins A, D, B1, B12; and parathyroid hormone at baseline and annually for 5 years. General linear mixed models were used to examine changes over time and identify factors associated with nutritional deficiencies. RESULTS: The participants were 75% female and 72% white, with a mean age of 16.5 ± 1.6 years and mean body mass index of 52.7 ± 9.4 kg/m2 at surgery. Mean body mass index decreased 23% at 5 years, and did not differ significantly between procedures. After RYGB, but not VSG, serum concentrations of vitamin B12 significantly decreased whereas serum levels of transferrin and parathyroid hormone increased. Ferritin levels decreased significantly after both procedures. Hypo-ferritinemia was observed in 2.5% of patients before RYGB and 71% at 5 y after RYGB (P < .0001), and 11% of patients before VSG and 45% 5 y after VSG (P = .002). No significant changes in serum levels of folate or vitamins A, B1, or D were found between baseline and 5 y after either procedure. By 5 y, 59% of RYGB and 27% of VSG recipients had 2 or more nutritional deficiencies. Risk factors associated with specific deficiencies included surgery type, female sex, black race, supplementation intake, weight regain, and for females, pregnancy. CONCLUSIONS: In a prospective study of adolescents who underwent RYGB or VSG, we observed nutritional deficiencies by 5 y after the procedures-particularly in iron and B12 after RYGB. Ongoing nutrient monitoring and supplementation are recommended for all patients, but surgery type, supplementation intake, sex, and race might affect risk. (Clinical trial registration: Adolescent Bariatrics: Assessing Health Benefits and Risk [also known as Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS)], NCT00474318.).


Subject(s)
Bariatric Surgery , Gastric Bypass , Obesity, Morbid , Adolescent , Bariatric Surgery/adverse effects , Female , Gastrectomy , Gastric Bypass/adverse effects , Humans , Male , Obesity, Morbid/surgery , Prospective Studies
15.
JAMA ; 324(9): 879-887, 2020 09 01.
Article in English | MEDLINE | ID: mdl-32870301

ABSTRACT

Importance: Severe obesity and its related diseases, such as type 2 diabetes, hypertension, dyslipidemia, and sleep apnea, are very common in the United States, but currently very few patients with these conditions choose to undergo bariatric surgery. Summaries of the expanding evidence for both the benefits and risks of bariatric surgery are needed to better guide shared decision-making conversations. Observations: There are approximately 252 000 bariatric procedures (per 2018 numbers) performed each year in the US, of which an estimated 15% are revisions. The 1991 National Institutes of Health guidelines recommended consideration of bariatric surgery in patients with a body mass index (calculated as weight in kilograms divided by height in meters squared) of 40 or higher or 35 or higher with serious obesity-related comorbidities. These guidelines are still widely used; however, there is increasing evidence that bariatric procedures should also be considered for patients with type 2 diabetes and a body mass index of 30 to 35 if hyperglycemia is inadequately controlled despite optimal medical treatment for type 2 diabetes. Substantial evidence indicates that surgery results in greater improvements in weight loss and type 2 diabetes outcomes, compared with nonsurgical interventions, regardless of the type of procedures used. The 2 most common procedures used currently, the sleeve gastrectomy and gastric bypass, have similar effects on weight loss and diabetes outcomes and similar safety through at least 5-year follow-up. However, emerging evidence suggests that the sleeve procedure is associated with fewer reoperations, and the bypass procedure may lead to more durable weight loss and glycemic control. Although safety is a concern, current data indicate that the perioperative mortality rates range from 0.03% to 0.2%, which has substantially improved since early 2000s. More long-term randomized studies are needed to assess the effect of bariatric procedures on cardiovascular disease, cancer, and other health outcomes and to evaluate emerging newer procedures. Conclusions and Relevance: Modern bariatric procedures have strong evidence of efficacy and safety. All patients with severe obesity-and especially those with type 2 diabetes-should be engaged in a shared decision-making conversation about the risks and benefits of surgery compared with continuing usual medical and lifestyle treatment, and the decision about surgery should be driven primarily by informed patient preferences.


Subject(s)
Bariatric Surgery , Obesity, Morbid/surgery , Postoperative Complications , Weight Loss , Bariatric Surgery/adverse effects , Bariatric Surgery/methods , Diabetes Mellitus, Type 2/complications , Dyslipidemias/etiology , Female , Gastrectomy , Humans , Hypertension/etiology , Male , Obesity, Morbid/complications , Sleep Apnea Syndromes/etiology
16.
Ann Surg ; 269(6): 1001-1009, 2019 06.
Article in English | MEDLINE | ID: mdl-31082893

ABSTRACT

OBJECTIVE: The aim of this study was to determine the sensitivity and specificity of potential thresholds of alcohol use for identifying alcohol-related problems in women post-Roux-en-Y gastric bypass (RYGB). BACKGROUND: Despite evidence that RYGB alters alcohol pharmacokinetics and is associated with an increased risk for alcohol-related problems, the level of alcohol use that should prompt further screening for alcohol-related problems following RYGB is unclear. METHODS: The Longitudinal Assessment of Bariatric Surgery-2 is a prospective cohort study. Before surgery and annually for ≤7 years following surgery, participants completed the 10-item Alcohol Use Disorder Identification Test (AUDIT), which assesses past-year frequency and quantity of alcohol, frequency of consuming ≥6 drinks, and alcohol-related problems (ie, symptoms of alcohol dependence and/or alcohol-related harm). The AUDIT-Consumption (AUDIT-C) score was determined from the first 3 AUDIT items. RESULTS: Post-RYGB, 835 women reported current drinking at 1 or more annual assessment(s). Compared with higher frequency thresholds, drinking ≥2 times/month had the highest combined sensitivity (85.3%) and specificity (61.4%) for identifying alcohol-related problems. Compared with higher quantity thresholds, drinking ≥3 drinks/drinking day had the highest combined sensitivity (64.2%) and specificity (87.2%). An AUDIT-C score ≥3, versus other thresholds, had the highest combined sensitivity (76.4%) and specificity (81.6%). CONCLUSION: The sensitivity and specificity of these thresholds indicate assessment of alcohol consumption alone may be inadequate for identifying women at risk for alcohol-related problems post-RYGB. Additional screening tools for alcohol-related problems, which assess symptoms of alcohol-related problems, should be conducted in this population.


Subject(s)
Alcohol Drinking , Alcohol-Related Disorders/diagnosis , Gastric Bypass , Obesity, Morbid/psychology , Obesity, Morbid/surgery , Adult , Cohort Studies , Female , Humans , Middle Aged , Self Report , Sensitivity and Specificity
17.
N Engl J Med ; 374(2): 113-23, 2016 Jan 14.
Article in English | MEDLINE | ID: mdl-26544725

ABSTRACT

BACKGROUND: Bariatric surgery is increasingly considered for the treatment of adolescents with severe obesity, but few prospective adolescent-specific studies examining the efficacy and safety of weight-loss surgery are available to support clinical decision making. METHODS: We prospectively enrolled 242 adolescents undergoing weight-loss surgery at five U.S. centers. Patients undergoing Roux-en-Y gastric bypass (161 participants) or sleeve gastrectomy (67) were included in the analysis. Changes in body weight, coexisting conditions, cardiometabolic risk factors, and weight-related quality of life and postoperative complications were evaluated through 3 years after the procedure. RESULTS: The mean (±SD) baseline age of the participants was 17±1.6 years, and the mean body-mass index (the weight in kilograms divided by the square of the height in meters) was 53; 75% of the participants were female, and 72% were white. At 3 years after the procedure, the mean weight had decreased by 27% (95% confidence interval [CI], 25 to 29) in the total cohort, by 28% (95% CI, 25 to 30) among participants who underwent gastric bypass, and by 26% (95% CI, 22 to 30) among those who underwent sleeve gastrectomy. By 3 years after the procedure, remission of type 2 diabetes occurred in 95% (95% CI, 85 to 100) of participants who had had the condition at baseline, remission of abnormal kidney function occurred in 86% (95% CI, 72 to 100), remission of prediabetes in 76% (95% CI, 56 to 97), remission of elevated blood pressure in 74% (95% CI, 64 to 84), and remission of dyslipidemia in 66% (95% CI, 57 to 74). Weight-related quality of life also improved significantly. However, at 3 years after the bariatric procedure, hypoferritinemia was found in 57% (95% CI, 50 to 65) of the participants, and 13% (95% CI, 9 to 18) of the participants had undergone one or more additional intraabdominal procedures. CONCLUSIONS: In this multicenter, prospective study of bariatric surgery in adolescents, we found significant improvements in weight, cardiometabolic health, and weight-related quality of life at 3 years after the procedure. Risks associated with surgery included specific micronutrient deficiencies and the need for additional abdominal procedures. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; Teen-LABS ClinicalTrials.gov number, NCT00474318.).


Subject(s)
Bariatric Surgery , Obesity, Morbid/surgery , Quality of Life , Weight Loss , Adolescent , Bariatric Surgery/methods , Body Mass Index , Dyslipidemias/complications , Dyslipidemias/epidemiology , Female , Humans , Hypertension/complications , Male , Malnutrition/etiology , Obesity, Morbid/complications , Postoperative Complications , Prevalence , Prospective Studies , Reoperation/statistics & numerical data , Risk Factors , Young Adult
18.
Int J Obes (Lond) ; 43(2): 285-296, 2019 02.
Article in English | MEDLINE | ID: mdl-29777230

ABSTRACT

BACKGROUND: The utility of serum biomarkers related to inflammation and adiposity as predictors of metabolic disease prevalence and outcomes after bariatric surgery are not well-defined. METHODS: Associations between pre- and post-operative serum levels of four biomarkers (C-reactive protein (CRP), cystatin C (CC), leptin, and ghrelin) with baseline measures of adiposity and metabolic disease prevalence (asthma, diabetes, sleep apnea), and weight loss and metabolic disease remission after bariatric surgery were studied in the Longitudinal Assessment of Bariatric Surgery (LABS) cohort. RESULTS: Baseline CRP levels were positively associated with the odds of asthma but not diabetes or sleep apnea; baseline CC levels were positively associated with asthma, diabetes, and sleep apnea; baseline leptin levels were positively associated with asthma and negatively associated with diabetes and sleep apnea; baseline ghrelin levels were negatively associated with diabetes and sleep apnea. Increased weight loss was associated with increased baseline levels of leptin and CRP and decreased baseline levels of CC. Remission of diabetes and asthma was not associated with baseline levels of any biomarker. A higher likelihood of asthma remission was associated with a greater decrease in leptin levels, and a higher likelihood of diabetes remission was predicted by a lesser decrease in CC. Bariatric surgery was associated with decreased post-operative CC, CRP, and leptin levels, and increased post-operative ghrelin levels. CONCLUSION: This is the largest study to date of serum biomarkers of inflammation and adiposity in a bariatric surgery cohort. Biomarker levels correlate with metabolic disease prevalence prior to bariatric surgery, and with weight loss but not metabolic disease remission after surgery. Bariatric surgery regulates serum biomarker levels in a manner consistent with anti-inflammatory and compensatory orexigenic effects. These data contribute to our understanding of the mechanisms underlying the biologic effects of bariatric surgery.


Subject(s)
Bariatric Surgery/statistics & numerical data , Inflammation , Metabolic Diseases , Obesity , Adiposity/physiology , Adult , Biomarkers/blood , C-Reactive Protein/analysis , Female , Ghrelin/blood , Humans , Inflammation/blood , Inflammation/epidemiology , Leptin/blood , Longitudinal Studies , Male , Metabolic Diseases/blood , Metabolic Diseases/epidemiology , Middle Aged , Obesity/blood , Obesity/epidemiology , Obesity/surgery , Treatment Outcome
19.
Alcohol Clin Exp Res ; 43(7): 1498-1509, 2019 07.
Article in English | MEDLINE | ID: mdl-31034607

ABSTRACT

BACKGROUND: Understanding whether the associations between alcohol use and alcohol use disorder (AUD) differ by weight status may be useful in screening for AUD in populations where obesity is common. We aimed to determine whether the associations between alcohol use and AUD differ by weight status. METHODS: A total of 24,869 adult participants of the National Epidemiologic Survey on Alcohol and Related Conditions-III with a body mass index ≥18.5 kg/m2 who reported past-year alcohol use were included. The AUD and Associated Disabilities Interview Schedule-5 were administered to identify past-year AUD. Logistic regression was used to test the associations between weight status and levels and patterns of alcohol use with AUD; interactions between weight status and alcohol use variables in relation to AUD were examined. Analyses were stratified by gender. RESULTS: For males and females, the odds of AUD were higher with greater frequency of any alcohol use and heavy drinking, higher average quantity of drinks per drinking day, and past-year high-risk drinking. Among males, at the same average quantity of drinks per drinking day, frequency of heavy drinking, or presence of high-risk drinking, those with class 3 obesity had higher odds of AUD versus lower classes or no obesity (p for all interactions <0.01). Among females, at the same frequency of any alcohol use, those with healthy weight had the highest odds of AUD, while females with class 3 obesity had the lowest odds of AUD (p for interaction <0.001); interactions between weight status and other alcohol use variables were not significant (p ≥ 0.05). CONCLUSIONS: The associations between some measures of alcohol use and AUD differed by weight status, with inconsistent results between males and females. Alcohol use thresholds typically used in AUD screening may be too high in males with class 3 obesity.


Subject(s)
Alcohol Drinking/adverse effects , Alcohol Drinking/epidemiology , Alcohol-Induced Disorders/complications , Alcohol-Induced Disorders/epidemiology , Alcohol-Related Disorders/complications , Alcohol-Related Disorders/epidemiology , Alcoholism/complications , Alcoholism/epidemiology , Body Weight , Adolescent , Adult , Aged , Aged, 80 and over , Cross-Sectional Studies , Disability Evaluation , Female , Humans , Male , Middle Aged , Obesity/complications , Prevalence , Sex Factors , Socioeconomic Factors , United States/epidemiology , Young Adult
20.
Appetite ; 142: 104366, 2019 11 01.
Article in English | MEDLINE | ID: mdl-31301320

ABSTRACT

BACKGROUND: Obesity is a chronic condition that has an intergenerational effect. The aims of the study were to better understand the impact of maternal bariatric surgery on obesogenic risks to child offspring in the home via documenting mothers' thoughts, behaviors, and experiences around child feeding, family meals, and the home food environment during her first year postsurgery. METHOD: Utilizing a mixed-method cross-sectional design, 20 mothers (Mage = 39.6 ±â€¯5.7 years, 75% White, MBMI = 33.6 ±â€¯4.3 kg/m2, Mtime = 7.7 ±â€¯3.1 months post-surgery) of children ages 6-12 years completed validated self-report measures and participated in a focus group. Mother and child heights/weights were measured. RESULTS: The majority of children (N = 20; Mage = 9.2 ±â€¯2.3 years, 65% White, 60% female) were overweight (N = 12; BMI≥85th percentile) and were not meeting the American Academy of Pediatrics healthy eating and activity recommendations to treat/reduce obesity risk. As child zBMI increased, mothers expressed significantly more weight concern (r = 0.59, p = 0.01) and lower obesity-specific quality of life (r = -0.56, p = 0.01), yet assumed less responsibility for child eating choices (r = -0.47, p = 0.04). Qualitative data demonstrated disconnects between mothers' changes to achieve her own healthier weight and applying this knowledge to feeding her child/family. CONCLUSIONS: While bariatric surgery and requisite lifestyle change are effective tools for weight loss at the individual level, there is a great need for innovative family-based solutions. Pediatric obesity is preventable or risk-diminished if addressed early. Maternal bariatric surgery may be a unique (yet missed) opportunity to intervene.


Subject(s)
Bariatric Surgery/psychology , Feeding Behavior/psychology , Maternal Behavior/psychology , Mothers/psychology , Pediatric Obesity/prevention & control , Adult , Body Mass Index , Child , Cross-Sectional Studies , Diet/statistics & numerical data , Diet, Healthy/statistics & numerical data , Exercise , Family Health/statistics & numerical data , Female , Focus Groups , Humans , Male , Middle Aged , Obesity/surgery , Overweight , Pediatric Obesity/epidemiology , Risk Factors
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