Sympathomimetic increases resting energy expenditure following bariatric surgery: A randomized controlled clinical trial.

OBJECTIVE: The aim of this study was to test the hypothesis that ephedrine + caffeine (EC) reduces the fall in resting energy expenditure (REE) following bariatric surgery. METHODS: This 32-week, randomized, double-blinded, placebo-controlled trial included 142 patients who underwent Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) surgery. Participants were randomized to either EC or placebo for 27 weeks, beginning 5 weeks post surgery. The primary end points were change in REE (measured), percentage of predicted REE ([measured REE/Harris-Benedict equation-predicted REE] × 100), and body composition. Secondary outcomes included change in percentage of weight. Adverse events (AEs) were recorded. RESULTS: The reduction in REE was smaller in the EC versus the placebo group, but it was not significant. Percentage of predicted REE was increased in the EC versus the placebo group (difference, mean [SE]: 5.82 [2.29], p = 0.013). Percentage of weight (difference: -3.83 [1.39], p = 0.007) was reduced in the EC versus the placebo group. Percentage of predicted REE was increased and body weight decreased in the EC-treated participants who underwent SG compared with those who underwent SG and were treated with placebo (difference in percentage of predicted REE = 8.06 [2.83], p = 0.006; difference in weight percentage = -4.37 [1.92], p = 0.025). Percentage of fat-free mass was increased in the SG participants treated with EC versus placebo (difference: 1.31 [0.63], p = 0.042). The most common AEs were anxiety, dizziness, insomnia, and tremors. Most AEs were not different from placebo by Week 32. CONCLUSIONS: EC enhances weight loss and reduces the fall in REE following bariatric surgery. Adrenergic symptoms mostly resolve over time.

Changes in weight control behaviors and hedonic hunger in a commercial weight management program adapted for individuals with type 2 diabetes.

BACKGROUND: A WW (formerly Weight Watchers) program adapted for persons with type 2 diabetes mellitus (T2DM) previously was found to be more effective than standard care (SC) intervention for weight loss, improved glycemic control, and weight- and diabetes-related quality of life measures. With data from the same national trial, this study examined whether WW adapted for persons with T2DM also increased engagement in weight control behaviors and decreased hedonic hunger, each of which could contribute to improved diabetes management. INTERVENTION AND METHODS: Individuals with T2DM (n = 563) and overweight or obesity participated in a 12-month, 16-site, randomized trial of WW with diabetes counseling or SC. Hierarchical linear modeling (HLM) evaluated whether 12-month changes in weight control behaviors (Eating Behavior Inventory; EBI) and hedonic hunger (Power of Food Scale; PFS) differed by treatment condition. If a significant treatment effect was found, 12-month changes in EBI/PFS were regressed on 12-month changes in HbA1c and percent weight loss to explore potential treatment differences in these associations. RESULTS: EBI scores increased significantly over the 12-months (p < 0.001), with greater improvements in WW than SC (p < 0.001). PFS decreased significantly in the 12-months (p < 0.001), with no differences between treatment groups (p = 0.15). HLM analyses that followed up on the significant treatment effect for 12-month change in EBI revealed no significant differences by treatment condition for the relationship between change in EBI scores and change in HbA1c (p = 0.14) or percent weight loss (p = 0.32). Across all participants, 12-month improvements in EBI and PFS were related to improved HbA1c (r = 0.22; -0.13, respectively) and greater percent weight loss (r = 0.41; -0.18, respectively) (ps < 0.01). CONCLUSIONS: WW with diabetes counseling produced greater engagement in weight control behaviors in those with T2DM than did SC. Across both groups, improved weight control behaviors and hedonic hunger were related to improved glycemic control and weight loss.

Impact on psychosocial outcomes of a nationally available weight management program tailored for individuals with type 2 diabetes: Results of a randomized controlled trial.

AIMS: Type 2 diabetes mellitus (T2DM) can substantially decrease quality of life (QOL). This study examined the effects on QOL-relevant psychosocial measures of a widely available commercial weight loss program enhanced for individuals with T2DM. METHODS: A year-long multi-site randomized clinical trial compared the Weight Watchers (WW) approach, supplemented with phone and email counseling with a certified diabetes educator (CDE), to brief standard diabetes nutrition counseling and education (Standard Care; SC). Participants were 400 women and 163 men (N=279 WW; 284 SC) with T2DM [mean (±SD) HbA1c 8.32±1%; BMI=37.1±5.7kg/m2; age=55.1 ± 9.1years]. Psychosocial outcomes were assessed at baseline, month 6, and month 12 using a diabetes specific psychosocial measure (Diabetes Distress Scale [DDS]), Impact of Weight on Quality of Life-Lite scale (IWQOL), a generic QOL measure (SF-36), and a depression screen (PHQ-9). RESULTS: WW participants showed significantly greater improvements than did SC participants on all DDS subscales and total score and on IWQOL total score and physical function, sex life and work domains (all ps<.05). There was no significant treatment effect on SF-36 scores or PHQ-9. CONCLUSIONS: WW enhanced for individuals with T2DM was superior to SC in improving psychosocial outcomes most specific to T2DM and obesity. Available commercial WL programs, combined with scalable complementary program-specific diabetes counseling, may have benefits that extend to diabetes-related distress and weight-relevant QOL.

Randomized controlled trial of a nationally available weight control program tailored for adults with type 2 diabetes.

OBJECTIVE: Modest weight loss from clinical interventions improves glycemic control in type 2 diabetes (T2DM). Data are sparse on the effects of weight loss via commercial weight loss programs. This study examined the effects on glycemic control and weight loss of the standard Weight Watchers program, combined with telephone and email consultations with a certified diabetes educator (WW), compared with standard diabetes nutrition counseling and education (standard care, SC). METHODS: In a 12-month randomized controlled trial at 16 U.S. research centers, 563 adults with T2DM (HbA1c 7-11%; BMI 27-50 kg/m2 ) were assigned to either the commercially available WW program (regular community meetings, online tools), plus telephone and email counseling from a certified diabetes educator, or to SC (initial in-person diabetes nutrition counseling/education, with follow-up informational materials). RESULTS: Follow-up rate was 86%. Twelve-month HbA1c changes for WW and SC were -0.32 and +0.16, respectively; 24% of WW versus 14% of SC achieved HbA1c <7.0% (P = 0.004). Weight losses were -4.0% for WW and -1.9% for SC (Ps < 0.001). 26% of WW versus 12% of SC reduced diabetes medications (P < 0.001). WW participants had greater reductions in waist circumference (P < 0.001) and C-reactive protein (P = 0.02) but did not differ on other cardiovascular risk factors. CONCLUSIONS: Widely available commercial weight loss programs with community and online components, combined with scalable complementary diabetes education, may represent accessible and effective components of management plans for adults with overweight/obesity and T2DM.

Metabolic syndrome prevalence and associations in a bariatric surgery cohort from the Longitudinal Assessment of Bariatric Surgery-2 study.

BACKGROUND: Metabolic syndrome is associated with higher risk for cardiovascular disease, sleep apnea, and nonalcoholic steatohepatitis, all common conditions in patients referred for bariatric surgery, and it may predict early postoperative complications. The objective of this study was to determine the prevalence of metabolic syndrome, defined using updated National Cholesterol Education Program criteria, in adults undergoing bariatric surgery and compare the prevalence of baseline co-morbid conditions and select operative and 30-day postoperative outcomes by metabolic syndrome status. METHODS: Complete metabolic syndrome data were available for 2275 of 2458 participants enrolled in the Longitudinal Assessment of Bariatric Surgery-2 (LABS-2), an observational cohort study designed to evaluate long-term safety and efficacy of bariatric surgery in obese adults. RESULTS: The prevalence of metabolic syndrome was 79.9%. Compared to those without metabolic syndrome, those with metabolic syndrome were significantly more likely to be men, to have a higher prevalence of diabetes and prior cardiac events, to have enlarged livers and higher median levels of liver enzymes, a history of sleep apnea, and a longer length of stay after surgery following laparoscopic Roux-en-Y gastric bypass (RYGB) and gastric sleeves but not open RYGB or laparoscopic adjustable gastric banding. Metabolic syndrome status was not significantly related to duration of surgery or rates of composite end points of intraoperative events and 30-day major adverse surgical outcomes. CONCLUSIONS: Nearly four in five participants undergoing bariatric surgery presented with metabolic syndrome. Establishing a diagnosis of metabolic syndrome in bariatric surgery patients may identify a high-risk patient profile, but does not in itself confer a higher risk for short-term adverse postsurgery outcomes.

Assessment of obstructive sleep apnea in adults undergoing bariatric surgery in the longitudinal assessment of bariatric surgery-2 (LABS-2) study.

STUDY OBJECTIVES: Evaluate frequency of diagnostic testing for obstructive sleep apnea (OSA), prevalence of OSA, and factors independently associated with OSA status in adults undergoing bariatric surgery. DESIGN, SETTINGS AND INTERVENTIONS: Longitudinal Assessment of Bariatric Surgery-2 (LABS-2) is an observational cohort of 2,458 adults undergoing bariatric surgery at 10 U.S. hospitals. Within 30 days prior to surgery, researchers determined if participants had a diagnostic polysomnography (PSG) in the previous 12 months. When available, apnea-hypopnea index (AHI) was recorded. Based on medical records and participant report, research clinicians recorded OSA status and positive airway pressure (PAP) use. Participants completed the Berlin Questionnaire (BQ). Multivariable logistic regression was used to determine factors independently associated with AHI-confirmed OSA status. RESULTS: 28.7% (n = 693) of participants had a PSG within 12 months before surgery. Of subjects with AHI available (n = 509), 80.7% (n = 411) had OSA (AHI ≥ 5); 83.0% (n = 341) reported PAP use. In participants without a known AHI (n = 1,949), 45.4% (n = 884) had self-reported OSA; 81.2% (n = 718) reported PAP use. Self-reported history of snoring and pauses in breathing (odds ratio [OR] = 10.0; 95%, confidence interval [CI] = 4.8-20.6), male sex (OR = 5.1; 95% CI = 1.7-15.3), older age (OR = 1.4; 95% CI = 1.2-1.6 per 5 years), and larger sagittal abdominal diameter (OR = 1.8; 95% CI = 1.2-2.5 per 5 cm) were independently associated with a greater odds of confirmed OSA. CONCLUSIONS: Preoperative diagnostic testing for OSA was infrequent. Prevalence estimates of OSA differed greatly between those with and without a past-year AHI (81% vs. 46%, respectively). Most BQ responses did not differentiate OSA status, but endorsement of snoring and pauses in breathing was independently associated with presence of OSA.

Omentectomy added to Roux-en-Y gastric bypass surgery: a randomized, controlled trial.

BACKGROUND: Excess visceral adipose tissue predicts for incipient diabetes mellitus and cardiovascular disease. Human data are mixed regarding the benefits of selective visceral adipose tissue reduction. We investigated the effects of omentectomy added to laparoscopic Roux-en-Y gastric bypass on glucose homeostasis and lipids, inflammatory markers, and adipokines 90 days postoperatively in nondiabetic patients at the Legacy Good Samaritan Hospital and Oregon Health and Science University (Portland, OR). METHODS: A single-blind, randomized study of laparoscopic Roux-en-Y gastric bypass plus omentectomy versus laparoscopic Roux-en-Y gastric bypass alone in 28 subjects (7 men and 21 women). The groups were matched at baseline for gender, age, and body mass index (BMI). The eligibility criteria included age ≥18 years, BMI ≥40 and <50 kg/m(2) without co-morbid conditions or BMI ≥35 and <50 kg/m(2) with co-morbid conditions. The primary outcome measures were changes in the fasting plasma glucose, insulin, and homostatic model assessment of insulin resistance. The secondary measures were BMI and the high-sensitivity C-reactive protein, tumor necrosis factor-α, interleukin, total and high-molecular-weight adiponectin, fibrinogen, and plasminogen activator inhibitor-1 levels. RESULTS: After surgery, the BMI decreased significantly in both groups and was not different at the follow-up point. Although many outcome parameters improved with weight loss in both groups postoperatively, only the omentectomy group experienced statistically significant decreases in fasting glucose (P < .05), total (P = .004) and very-low-density lipoprotein (P = .001) cholesterol, and an increase in the high-molecular-weight/total adiponectin ratio (P = .013). CONCLUSIONS: Omentectomy added to laparoscopic Roux-en-Y gastric bypass results in favorable changes in glucose homeostasis, lipid levels, and adipokine profile at 90 days postoperatively. These data support the hypothesis that selective ablation of visceral adipose tissue conveys metabolic benefits in nondiabetic humans.

Creating a learning healthcare system in surgery: Washington State's Surgical Care and Outcomes Assessment Program (SCOAP) at 5 years.

There are increasing efforts towards improving the quality and safety of surgical care while decreasing the costs. In Washington state, there has been a regional and unique approach to surgical quality improvement. The development of the Surgical Care and Outcomes Assessment Program (SCOAP) was first described 5 years ago. SCOAP is a peer-to-peer collaborative that engages surgeons to determine the many process of care metrics that go into a "perfect" operation, track on risk adjusted outcomes that are specific to a given operation, and create interventions to correct under performance in both the use of these process measures and outcomes. SCOAP is a thematic departure from report card oriented QI. SCOAP builds off the collaboration and trust of the surgical community and strives for quality improvement by having peers change behaviors of one another. We provide, here, the progress of the SCOAP initiative and highlight its achievements and challenges.

No correlation between anti-factor Xa levels, low-molecular-weight heparin, and bleeding after gastric bypass.

BACKGROUND: Pulmonary embolism (PE) remains a leading cause of death after Roux-en-Y gastric bypass. Currently, various regimens of low-molecular-weight heparin (LMWH) are used for perioperative deep vein thrombosis (DVT) prophylaxis. Anti-factor Xa (AFXa) has been suggested as a potential marker of LMWH activity. We have developed a perioperative prophylactic DVT regimen for our bariatric patients in which the dosage of LMWH they receive is based on their body mass index (BMI). We looked at whether AFXa levels correlated with bleeding risk. METHODS: A retrospective, single institution review of 102 patients undergoing a gastric bypass from November 2003 to April 2004 was performed. Twelve patients received transfusions. AFXa levels were present for 7 of 12 patients requiring transfusions and 74 of 90 patients not requiring transfusions. The average AFXa level for each group was compared. RESULTS: The transfusion rate for the group was 11.7%, with an average of 2.6 units of blood given (SD 1.2). There was no statistical difference between the average AFXa value for transfused and nontransfused patients (0.13 +/- 0.08 vs. 0.16 +/- 0.19, P = .7). CONCLUSION: AFXa levels do not appear to correlate with bleeding risk in patients receiving LMWH prophylaxis following gastric bypass. Determining such risk seems to require another marker.

A description of morbidly obese state employees requesting a bariatric operation.

BACKGROUND: The federal government, the medical insurance industry, and the academic medical community have disagreed over what treatments are appropriate and cost effective for morbid obesity. This debate is hindered by inadequate data regarding the true costs of diseases and who chooses an operation as a treatment option. The purpose of this study was to obtain these costs and to describe this population. METHODS: Louisiana's managed medical insurance program created primarily for its civil service employees contracted to offer a small random group of morbidly obese employees the option of a bariatric operation. This observational study examined the subpopulation who requested consideration for the operation. We present historic cost data from all medical expenses paid by the insurance company, a telephone survey of the volunteers in the study to determine their medical problems, and diagnostic evaluation data on those employees randomized to proceed for possible bariatric operation. RESULTS: A total of 911 of 189,398 adult members of the insurance plan wanted to be considered for this study. Only 397, however, completed the informed-consent process. Of the 248 employees who met the age requirement, body mass index criteria, and health criteria to be considered for a bariatric operation and were randomized, 20 withdrew before obtaining 40 committed operative candidates. The 773 morbidly obese female members had used a mean of dollar 11,145 in medical insurance expenses in the year 2003 versus a mean of dollar 8,096 for the other 106,908 adult women. Similar values for the men were dollar 16,720 for the 138 morbidly obese men versus dollar 5,943 for the other 82,490 men. CONCLUSIONS: The morbidly obese members of this medical insurance plan who requested a bariatric operation are costing their plan 1.4 to 2.8 times the yearly amount of the other adult members in medical expenses. The yearly mean amount the insurance plan spends on these members suggests that operative treatment would pay for itself in a relatively few number of years if it could significantly reduce these costs. Even in those who consider bariatric operation, many withdraw, further limiting the costs of operative therapy.

Bariatric surgery.

The surgical treatment of obesity is indicated in patients who have failed sincere attempts at medical therapies to lose weight. The BMI must exceed 40 or exceed 35 and be associated with at least two comorbid conditions. Comorbid conditions include diabetes mellitus, hypertension, obstructive sleep apnea, hyperlipidemia, and other weight related conditions that may benefit from weight loss. Patients need to be educated concerning the specific operation to be performed. They must be taught what they need to do to optimize the likelihood of success of the surgery, and they must have an understanding concerning the potential adverse side effects. When this format is followed, bariatric surgery is a legitimate treatment for morbid obesity, and the only treatment that is generally successful.