Clinical outcomes and adverse events of bariatric surgery in adults with severe obesity in Scotland: the SCOTS observational cohort study.

Background: Bariatric surgery is a common procedure worldwide for the treatment of severe obesity and associated comorbid conditions but there is a lack of evidence as to medium-term safety and effectiveness outcomes in a United Kingdom setting. Objective: To establish the clinical outcomes and adverse events of different bariatric surgical procedures, their impact on quality of life and the effect on comorbidities. Design: Prospective observational cohort study. Setting: National Health Service secondary care and private practice in Scotland, United Kingdom. Participants: Adults (age >16 years) undergoing their first bariatric surgery procedure. Main outcome measures: Change in weight, hospital length of stay, readmission and reoperation rate, mortality, diabetes outcomes (HbA1c, medications), quality of life, anxiety, depression. Data sources: Patient-reported outcome measures, hospital records, national electronic health records (Scottish Morbidity Record 01, Scottish Care Information Diabetes, National Records Scotland, Prescription Information System). Results: Between December 2013 and February 2017, 548 eligible patients were approached and 445 participants were enrolled in the study. Of those, 335 had bariatric surgery and 1 withdrew from the study. Mean age was 46.0 (9.2) years, 74.7% were female and the median body mass index was 46.4 (42.4; 52.0) kg/m2. Weight was available for 128 participants at 3 years: mean change was -19.0% (±14.1) from the operation and -24.2% (±12.8) from the start of the preoperative weight-management programme. One hundred and thirty-nine (41.4%) participants were readmitted to hospital in the same or subsequent 35 months post surgery, 18 (5.4% of the operated cohort) had a reoperation or procedure considered to be related to bariatric surgery gastrointestinal complications or revisions. Fewer than five participants (<2%) died during follow-up. HbA1c was available for 93/182 and diabetes medications for 139/182 participants who had type 2 diabetes prior to surgery; HbA1c mean change was -5.72 (±16.71) (p = 0.001) mmol/mol and 65.5% required no diabetes medications (p < 0.001) at 3 years post surgery. Physical quality of life, available for 101/335 participants, improved in the 3 years post surgery, mean change in Rand 12-item Short Form Survey physical component score 8.32 (±8.95) (p < 0.001); however, there was no change in the prevalence of anxiety or depression. Limitations: Due to low numbers of bariatric surgery procedures in Scotland, recruitment was stopped before achieving the intended 2000 participants and follow-up was reduced from 10 years to 3 years. Conclusions: Bariatric surgery is a safe and effective treatment for obesity. Patients in Scotland, UK, appear to be older and have higher body mass than international comparators, which may be due to the small number of procedures performed. Future work: Intervention studies are required to identify the optimal pre- and post surgery pathway to maximise safety and cost-effectiveness. Study registration: This study is registered as ISRCTN47072588. Funding details: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 10/42/02) and is published in full in Health Technology Assessment; Vol. 28, No. 7. See the NIHR Funding and Awards website for further award information.

Bariatric surgery is performed on the stomach and small bowel to help people living with obesity lose weight. Our research study has looked at who is getting bariatric surgery, if they are having problems afterwards, how much weight they lose and if their medical conditions improve. A total of 444 people who were attending bariatric surgery services in Scotland, UK, agreed to take part and 336 had surgery. One hundred and eighty-nine of them completed a questionnaire before their surgery and 85 of them after 3 years, to tell us about how they were feeling physically and mentally. We looked at their computer hospital records to see how long they spent in hospital, any medical problems and changes to diabetes medicines and tests. One in five people taking part did not have surgery after all; they changed their mind or the hospital teams did not think it would be safe or work well for the patient. Those who had surgery lost 19% of their body weight and those with type 2 diabetes needed less or no medication 3 years after the surgery. The effect of physical symptoms on day-to-day activities improved but mental health did not. Compared to other countries, the people taking part were older, heavier and sicker. They spent longer in hospital after surgery and were more likely to be readmitted to hospital. How many appointments they had or what type of health professional they saw before or after surgery did not change these results. We had hoped to have far more people in this study and be able to answer more questions, but not enough people were getting bariatric surgery in Scotland for us to ask them to take part. Further research is needed to find the best ways to care for people living with obesity who would benefit from bariatric surgery.

Comparison of health care costs following sleeve gastrectomy versus Roux-en-Y gastric bypass among patients with type 2 diabetes.

OBJECTIVE: The objective of this study was to compare the impact of sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) on overall and diabetes-specific health care costs among patients with type 2 diabetes. METHODS: This retrospective cohort study examined patients with type 2 diabetes after SG and RYGB using data from Optum's deidentified Clinformatics® Data Mart database. The matched study group included 9608 patients who underwent SG or RYGB and were enrolled between 2007 and 2019. The primary outcomes assessed were overall and diabetes-specific health care costs. RESULTS: Health care costs associated with type 2 diabetes declined substantially in the first few years following both SG and RYGB. RYGB was associated with a larger decrease in pharmacy costs, as well as type 2 diabetes-specific office and laboratory costs. SG was associated with lower total health care costs in the first three follow-up periods and lower acute care costs in the first 2 years after surgery. CONCLUSIONS: In this nationwide study, patients with type 2 diabetes at baseline undergoing RYGB appear to experience a reduced need for ambulatory type 2 diabetes monitoring and reduced requirements for antidiabetes medication but, despite this, did not experience an overall medical cost-benefit in the first few years after RYGB versus SG.

French National Authority for Health assessment of metabolic surgery for type 2 diabetes remission-A meta-analysis in patients with class I to III obesity.

OBJECTIVE: Randomized controlled trials (RCTs) have demonstrated the superiority of metabolic surgery (MS) over medical therapy (MT) in patients with obesity and type 2 diabetes, leading, to a joint statement in 2016 proposing MS to patients with class I obesity and uncontrolled glycemia. Yet, these RCTs included few patients with class I obesity (body mass index 30-35 kg/m2) and even fewer patients with overweight. Our aim was to provide an updated systematic review (SR) with meta-analysis (MA) of RCTs reporting diabetes remission (DR) after MS in these patients. RESEARCH DESIGN AND METHODS: We included in the SR with MA only RCTs with at least 24-month follow-up found in Medline, Cochrane Library, Embase, and LiSSA between January 2008 and September 2022 comparing DR post-MT versus post-MS. We calculated relative risk (RR) and 95 % confidence intervals (CIs) using the Mantel-Haenszel random-effects approach to examine differences in DR between patients allocated to MS versus MT. RESULTS: DR was significantly higher in MS versus MT after 36 months' follow-up in patients with obesity (RR = 6.65 [95 %CI 2.24;19.79]; I² = 27 %; 5 trials, 404 patients), but also specifically in patients with class I obesity (RR = 5.27 [1.31;21.23]; I² = 0 %; 4 trials, 80 patients). Furthermore, and in line with previous results, all additional MAs performed in patients with obesity in this work favor MS (specifically Roux-en-Y gastric bypass) over MT at 24, 36 (only) and 60 months of follow-up. CONCLUSIONS: Although the data available in patients with class I obesity and type 2 diabetes remains limited, MA shows higher rates of DR after MS compared with MT after 36 months' follow-up in these patients. Consequently, the French National Authority for Health French (HAS) recommends MS for these patients.

Bariatric Surgery for Adults With Class I Obesity and Difficult-to-Manage Type 2 Diabetes: A Health Technology Assessment.

Background: Many individuals with type 2 diabetes are classified as either overweight or obese. A patient may be described as having difficult-to-manage type 2 diabetes if their HbA1c levels remain above recommended target levels, despite efforts to treat it with lifestyle changes and pharmacotherapy. Bariatric surgery refers to procedures that modify the gastrointestinal tract. In patients with class II or III obesity, bariatric surgery has resulted in substantial weight loss, improved quality of life, reduced mortality risk, and resolution of type 2 diabetes. There is some evidence suggesting these outcomes may also be possible for patients with class I obesity as well. We conducted a health technology assessment of bariatric surgery for adults with class I obesity and difficult-to-manage type 2 diabetes, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding bariatric surgery, and patient preferences and values. Methods: We performed a systematic clinical literature review. We assessed the risk of bias of each included study, using the Cochrane Risk of Bias tool for randomized controlled trials, the Risk of Bias in Non-randomized Studies - of Interventions (ROBINS-I) tool for cohort studies, and the Risk of Bias in Systematic Reviews (ROBIS) tool for systematic reviews; we assessed the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature review and conducted a cost-utility analysis of bariatric surgery in comparison with nonsurgical usual care over a lifetime horizon from a public payer perspective. We also analyzed the budget impact of publicly funding bariatric surgery for adults with class I obesity and difficult-to-manage type 2 diabetes in Ontario. To contextualize the potential value of bariatric surgery, we spoke with people with obesity and type 2 diabetes who had undergone or were considering this procedure. Results: We included 14 studies in the clinical evidence review. There were large increases in diabetes remission rates (GRADE: Low to Very low) and large reductions in body mass index (GRADE: Low to Very low) with bariatric surgery than with medical management. Bariatric surgery may also reduce the use of medications for type 2 diabetes (GRADE: Low) and may improve quality of life for people with class I obesity and difficult-to-manage type 2 diabetes compared with medical management. (GRADE: Low)Our economic evidence review included 5 cost-effectiveness studies; none were conducted in a Canadian setting, and 4 were considered partially applicable to our research question. Most studies found bariatric surgery to be cost-effective compared to standard care for patients with class I obesity and type 2 diabetes; however, the applicability of these results to the Ontario context is uncertain due to potential differences in clinical practice, resource utilization, and unit costs.Our primary economic evaluation found that over a lifetime horizon, bariatric surgery was more costly (incremental cost: $8,151 per person) but also more effective than current usual care (led to a 0.339 quality-adjusted life-year [QALY] gain per person). The cost increase was driven by costs associated with surgery (before, after, and during surgery), and the QALY gain was due to life-years gained. Results were sensitive to the bariatric surgery cost and assumptions regarding its long-term benefits with respect to weight loss and diabetes remission.Publicly funding 50 bariatric surgeries in year 1, and gradually increasing to 250 surgeries in year 5, for people with class I obesity and difficult-to-manage type 2 diabetes would lead to budget increases of $0.55 million in year 1 to $2.45 million in year 5, for a total of $7.63 million over 5 years.The people with obesity and type 2 diabetes with whom we spoke reported that bariatric surgery was generally seen as a positive treatment option, and those who had undergone the procedure reported positively on its value as a treatment to manage their weight and diabetes. Conclusions: For adults with class I obesity and difficult-to-manage type 2 diabetes, bariatric surgery may be more clinically effective and cost-effective than medical management. Compared with medical management in people with class I obesity and difficult-to-manage type 2 diabetes, bariatric surgery may result in large increases in diabetes remission rates, large reductions in BMI, and reduced medication use for type 2 diabetes, improved quality of life. Over a lifetime horizon, bariatric surgery led to a cost increase and QALY gain. Bariatric surgery can result in postsurgical complications that are not faced by those receiving medical management. The cost-effectiveness of bariatric surgery depends on its long-term impacts on obesity-related and diabetes-related complications, which could be uncertain.Our budget impact analysis suggests that publicly funding bariatric surgery in Ontario for people with class I obesity and difficult-to-manage type 2 diabetes would lead to a budget increase of $7.63 million over 5 years.For people with obesity and type 2 diabetes, bariatric surgery was seen as a potential positive treatment option to manage their weight and diabetes.

Cost-Effectiveness of Bariatric Surgery in Patients Living with Obesity and Type 2 Diabetes.

Aims: The favourable effects of bariatric surgeries on body weight reduction and glucose control have been demonstrated in several studies. Additionally, the cost-effectiveness of bariatric surgeries has been confirmed in several analyses. The aim of the current analysis was to demonstrate the cost-effectiveness of bariatric surgeries in obese patients with type 2 diabetes in Hungary compared to conventional diabetes treatments based on economic modelling of published clinical trial results. Materials and Methods: Patients entered the simulation model at the age of 45 with body mass index (BMI) ≥ 30 kg/m2 and type 2 diabetes. The model was performed from the public payer's perspective, comparing sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) procedures to conventional care of diabetes. The results were provided separately for three BMI categories. Results: The base-case analysis demonstrated that both surgery types were dominant; i.e., they saved 17 064 to 24 384 Euro public payer expenditures and resulted in improved health outcomes (1.36 to 1.50 quality-adjusted life years gain (QALY)) in the three BMI categories. Bariatric surgeries extended the life expectancy and the disease-free survival times of all the investigated diabetes complications. All the scenario analyses confirmed the robustness of the base-case analysis, such that bariatric surgeries remained dominant compared to conventional diabetes treatments. Conclusion: The results of this cost-effectiveness analysis highlight the importance of bariatric surgeries as alternatives to conventional diabetes treatments in the obese population. Therefore, it is strongly recommended that a wider population has access to these surgeries in Hungary.

Type 2 Diabetes Remission After Bariatric Surgery and Its Impact on Healthcare Costs.

PURPOSE: Bariatric surgery is the most effective and durable treatment of obesity and can put type 2 diabetes (T2D) into remission. We aimed to examine remission rates after bariatric surgery and the impacts of post-surgical healthcare costs. MATERIALS AND METHODS: Obese adults with T2D were identified in Merative™ (US employer-based retrospective claims database). Individuals who had bariatric surgery were matched 1:1 with those who did not with baseline demographic and health characteristics. Rates of remission and total healthcare costs were compared at 6-12 and 6-36 months after the index date. RESULTS: Remission rates varied substantially by baseline T2D complexity; differences in rates at 1 year ranged from 41% for those with high-complexity T2D to 66% for those with low- to mid-complexity T2D. At 3 years, those who had bariatric surgery had 56% higher remission rates than those who did not have bariatric surgery, with differences of 73%, 59%, and 35% for those with low-, mid-, and high-complexity T2D at baseline. Healthcare costs were $3401 and $20,378 lower among those who had bariatric surgery in the 6 to 12 months and 6 to 36 months after the index date, respectively, than their matched controls. The biggest cost differences were seen among those with high-complexity T2D; those who had bariatric surgery had $26,879 lower healthcare costs in the 6 to 36 months after the index date than those who did not. CONCLUSION: Individuals with T2D undergoing bariatric surgery have substantially higher rates of T2D remission and lower healthcare costs.

LAPAROSCOPIC BARIATRIC SURGERY IN ADOLESCENTS: EARLY AND FIVE- YEAR CLINICAL AND LABORATORY ASSESSMENT.

BACKGROUND: Obesity has reached epidemic proportions among adolescents. Methods, such as bariatric surgery, have become the most effective treatment for patients with classes III and IV obesity. AIM: To evaluate weight loss, comorbidity remission, and long-term results of bariatric surgery in adolescents. METHODS: Study with adolescent patients undergoing bariatric surgery, evaluating laboratory tests, comorbidities, and the percentage of excess weight loss in the preoperative period and at one, two, and five years postoperatively. RESULTS: A total of 65 patients who met the inclusion criteria, with a mean age of 18.6 years, were included in the analysis. In the preoperative period, 30.8% of hypercholesterolemia, 23.1% of systemic arterial hypertension, and 18.4% of type 2 diabetes were recorded, with remission of these percentages occurring in 60, 66.7 and 83.4%, respectively. The mean percentage of excess weight loss was 63.48% after one year of surgery, 64.75% after two years, and 57.28% after five years. The mean preoperative total cholesterol level was 180.26 mg/dL, and after one, two, and five years, it was 156.89 mg/dL, 161.39 mg/dL, and 150.97 mg/dL, respectively. The initial mean of low-density lipoprotein was 102.19mg/dL and after five years the mean value reduced to 81.81 mg/dL. The mean preoperative glycemia was 85.08 mg/dL and reduced to 79.13 mg/dL after one year, and to 76.19 mg/dL after five years. CONCLUSIONS: Bariatric surgery is safe and effective in adolescents, with low morbidity, resulting in a loss of excess weight and long-term stability, improving laboratory tests, and leading to remission of comorbidities, such as diabetes mellitus, hypercholesterolemia, and systemic arterial hypertension.

The remission rate, metabolic changes, and quality of life assessment among patients with type 2 diabetes post-bariatric surgery in Riyadh, Saudi Arabia: A cross-sectional study.

OBJECTIVES: To assess the remission rate, metabolic changes, and quality of life after bariatric surgery among Saudi patients with type 2 diabetes (T2DM). METHODS: This cross-sectional study was conducted in 2 main centers in the Riyadh, Saudi Arabia. The study included patients with T2DM who underwent either laparoscopic sleeve gastrectomy (LSG) or Roux-en-Y gastric bypass (RYGB) surgery from 2014 to 2018. The remission rate was defined based on the American Diabetes Association (ADA) and the International Diabetes Federation (IDF) criteria. Quality of life was assessed using the World Health Organization Quality of Life (WHOQOL)-BREF. RESULTS: A total of 232 patients were included with a mean age of 44.3 ± 10.3 years. 93.4% of the patients had LSG, while only 6.6% had RYGB surgery. Among patients who underwent either LSG or RYGB surgery, there was a significant improvement in metabolic and glycemic markers compared to the baseline. According to the ADA criteria, 48.5% of the patients had complete remission, while 18.9% had partial remission. Overall, 7% of the patients met the IDF optimization criteria, while 5.7% met the IDF improvement criteria. The mean score for all the QOL domains exceeded 63 ± 13, with the environmental and physical health domains having the highest scores. CONCLUSION: Among Saudi patients, bariatric surgery was associated with high remission rates and a better quality of life.

The Long-term Value of Bariatric Surgery Interventions for American Adults With Type 2 Diabetes Mellitus.

BACKGROUND: Bariatric surgery can cause type 2 diabetes (diabetes) remission for individuals with comorbid obesity, yet utilization is <1%. Surgery eligibility is currently limited to body mass index (BMI) ≥35 kg/m 2 , though the American Diabetes Association recommends expansion to BMI ≥30 kg/m 2 . OBJECTIVE: We estimate the individual-level net social value benefits of diabetes remission through bariatric surgery and compare the population-level effects of expanding eligibility alone versus improving utilization for currently eligible individuals. METHODS: Using microsimulation, we quantified the net social value (difference in lifetime health/economic benefits and costs) of bariatric surgery-related diabetes remission for Americans with obesity and diabetes. We compared projected lifetime surgical outcomes to conventional management at individual and population levels for current utilization (1%) and eligibility (BMI ≥35 kg/m 2 ) and expansions of both (>1%, and BMI ≥30 kg/m 2 ). RESULTS: The per capita net social value of bariatric surgery-related diabetes remission was $264,670 (95% confidence interval: $234,527-294,814) under current and $227,114 (95% confidence interval: $205,300-248,928) under expanded eligibility, an 11.1% and 9.16% improvement over conventional management. Quality-adjusted life expectancy represented the largest gains (current: $194,706; expanded: $169,002); followed by earnings ($51,395 and $46,466), and medical savings ($41,769 and $34,866) balanced against the surgery cost ($23,200). Doubling surgical utilization for currently eligible patients provides higher population gains ($34.9B) than only expanding eligibility at current utilization ($29.0B). CONCLUSIONS: Diabetes remission following bariatric surgery improves healthy life expectancy and provides net social benefit despite high procedural costs. Per capita benefits appear greater among currently eligible individuals. Therefore, policies that increase utilization may produce larger societal value than expanding eligibility criteria alone.

Cost-effectiveness of metabolic surgery for the treatment of type 2 diabetes and obesity: a systematic review of economic evaluations.

AIM: To systematically identify and appraise the international literature on the cost-effectiveness of metabolic surgery for the treatment of comorbid type 2 diabetes (T2D) and obesity. METHODS: A systematic search was conducted in electronic databases and grey literature sources up to 20 January 2021. Economic evaluations in a T2D population or a subpopulation with T2D were eligible for inclusion. Screening, data extraction, critical appraisal of methodological quality (Consensus Health Economic Criteria list) and assessment of transferability (International Society for Pharmacoeconomics and Outcomes Research questionnaire) were undertaken in duplicate. The incremental cost-effectiveness ratio (ICER) was the main outcome. Costs were reported in 2020 Irish Euro. Cost-effectiveness was interpreted using willingness-to-pay (WTP) thresholds of €20,000 and €45,000/quality-adjusted life year (QALY). Due to heterogeneity arising from various sources, a narrative synthesis was undertaken. RESULTS: Thirty studies across seventeen jurisdictions met the inclusion criteria; 16 specifically in a T2D population and 14 in a subpopulation with T2D. Overall, metabolic surgery was found to be cost-effective or cost-saving. Where undertaken, the results were robust to sensitivity and scenario analyses. Of the 30 studies included, 15 were considered high quality. Identified limitations included limited long-term follow-up data and uncertainty regarding the utility associated with T2D remission. CONCLUSION: Published high-quality studies suggest metabolic surgery is a cost-effective or cost-saving intervention. As the prevalence of obesity and obesity-related diseases increases worldwide, significant investment and careful consideration of the resource requirements needed for metabolic surgery programmes will be necessary to ensure that service provision is adequate to meet demand.

Type 2 diabetes remission after Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy (SG), and one anastomosis gastric bypass (OAGB): results of the longitudinal assessment of bariatric surgery study.

BACKGROUND: Several studies on various bariatric surgeries involving patients with type 2 diabetes mellitus (T2DM) showed an overall rate of remission of hyperglycemia. However, there is little known about predictive factors on remission after different types of surgeries. The aim of this study was to identify the T2DM remission rate and to determine the effects of preoperative factors characteristics of remission of type 2 diabetes in Iran. METHODS: We conducted a retrospective analysis of 1351 patients with T2DM operated by three different types of surgeries (Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy (SG), and One Anastomosis Gastric Bypass (OAGB)). Diabetes remission was defined according to the American Diabetes Association (ADA) criteria. Binary logistic regression analyses were employed. RESULTS: A total of 1351 patients, 675 patients (50.0%) undergoing OAGB, 475 (35.2%) RYGB, and 201 (14.9%) SG. 80.6%, 84.2% of OAGB, 81.7%, 82.6% of RYGB, and 77.1%, 81.5% of SG participants were in T2DM remission after 1 and 3 years, respectively. 1- and 3-year remission were associated with preoperative age, duration of T2DM, FBS and HbA1c, BMI, insulin therapy, and a family history of obesity (p < 0.05). CONCLUSION: The remission of T2DM after RYGB, SG, and OAGB surgery is dependent on various preoperative factors. Patients with younger age, shorter duration of T2DM, lower preoperative HbA1c and FBS, higher BMI, who were not on insulin therapy, and not having a family history of obesity were the best candidates to achieve a prolonged diabetes remission.

Long-term Impact of Laparoscopic Sleeve Gastrectomy on Drug Costs of Japanese Patients with Obesity and Type 2 Diabetes Mellitus.

PURPOSE: Laparoscopic sleeve gastrectomy (LSG) is the most common type of bariatric surgery in Japan, and it is the only such procedure covered by national health insurance. The long-term cost of bariatric surgery in Japan has not yet been analyzed. We aimed to evaluate the long-term impact of LSG on the drug treatment costs of patients with type 2 diabetes mellitus (T2DM). MATERIALS AND METHODS: We retrospectively analyzed data from 230 patients who had undergone LSG at our institution for their obesity and T2DM between 2007 and 2018. The clinicopathological data included age, sex, body mass index (BMI), as well as preoperative and postoperative medications for T2DM, hypertension, and dyslipidemia. We then calculated the drug treatment costs for T2DM, hypertension, and dyslipidemia before and after LSG; and we evaluated the remission rates of these obesity-related diseases. RESULTS: The median preoperative body weight and BMI of the 230 patients who underwent LSG were 115 kg and 40.6 kg/m2, respectively. Preoperative drug treatment costs per month per patient for T2DM, hypertension, and dyslipidemia were ¥3795 (¥0-40285), ¥3269 (¥0-14577), and ¥1428 (¥0-19464). Post-operation, the median drug treatment costs for all these diseases became nil. The remission rates of T2DM, hypertension, and dyslipidemia 5 years after LSG were 82.8%, 50%, and 43.8%, respectively. In Japan, the cost of an LSG operation corresponds to 4.75 years of median drug costs to treat T2DM and hypertension. CONCLUSION: In the long term, LSG in Japan is effective both physically and cost-wise for patients with obesity and T2DM.

Sex-related disparities in the incidence and outcomes of hemorrhagic stroke among type 2 diabetes patients: a propensity score matching analysis using the Spanish National Hospital Discharge Database for the period 2016-18.

BACKGROUND: To analyze incidence, use of therapeutic procedures, use of oral anticoagulants (OACs) and antiplatelet agents prior to hospitalization, and in-hospital outcomes among patients who were hospitalized with hemorrhagic stroke (HS) according to the presence of type 2 diabetes mellitus (T2DM) in Spain (2016-2018) and to assess the role of sex differences among those with T2DM. METHODS: Using the Spanish National Hospital Discharge Database we estimated the incidence of HS hospitalizations in men and women aged ≥ 35 years with and without T2DM. Propensity score matching (PSM) was used to compare population subgroups according to sex and the presence of T2DM. RESULTS: HS was coded in 31,425 men and 24,975 women, of whom 11,915 (21.12%) had T2DM. The adjusted incidence of HS was significantly higher in patients with T2DM (both sexes) than in non-T2DM individuals (IRR 1.15; 95% CI 1.12-1.17). The incidence of HS was higher in men with T2DM than in T2DM women (adjusted IRR 1.60; 95% CI 1.57-1.63). After PSM, men and women with T2DM have significantly less frequently received decompressive craniectomy than those without T2DM. In-hospital mortality (IHM) was higher among T2DM women than matched non-T2DM women (32.89% vs 30.83%; p = 0.037), with no differences among men. Decompressive craniectomy was significantly more common in men than in matched women with T2DM (5.81% vs. 3.33%; p < 0.001). IHM was higher among T2DM women than T2DM men (32.89% vs. 28.28%; p < 0.001). After adjusting for confounders with multivariable logistic regression, women with T2DM had a 18% higher mortality risk than T2DM men (OR 1.18; 95% CI 1.07-1.29). Use of OACs and antiplatelet agents prior to hospitalization were associated to higher IHM in men and women with and without T2DM. CONCLUSIONS: T2DM is associated with a higher incidence of HS and with less frequent use of decompressive craniectomy in both sexes, but with higher IHM only among women. Sex differences were detected in T2DM patients who had experienced HS, with higher incidence rates, more frequent decompressive craniectomy, and lower IHM in men than in women.

Health service organisation impact on lower extremity amputations in people with type 2 diabetes with foot ulcers: systematic review and meta-analysis.

AIMS: Despite the evidence available on the epidemiology of diabetic foot ulcers and associated complications, it is not clear how specific organizational aspects of health care systems can positively affect their clinical trajectory. We aim to evaluate the impact of organizational aspects of care on lower extremity amputation rates among people with type 2 diabetes affected by foot ulcers. METHODS: We conducted a systematic review of the scientific literature published between 1999 and 2019, using the following key terms as search criteria: people with type 2 diabetes, diagnosed with diabetic foot ulcer, treated with specific processes and care pathways, and LEA as primary outcome. Overall results were reported as pooled odds ratios and 95% confidence intervals obtained using fixed and random effects models. RESULTS: A total of 57 studies were found eligible, highlighting the following arrangements: dedicated teams, care pathways and protocols, multidisciplinary teams, and combined interventions. Among them, seven studies qualified for a meta-analysis. According to the random effects model, interventions including any of the four arrangements were associated with a 29% reduced risk of any type of lower extremity amputation (OR = 0.71; 95% CI 0.52-0.96). The effect was larger when focusing on major LEAs alone, leading to a 48% risk reduction (OR = 0.52; 95% CI 0.30-0.91). CONCLUSIONS: Specific organizational arrangements including multidisciplinary teams and care pathways can prevent half of the amputations in people with diabetes and foot ulcers. Further studies using standardized criteria are needed to investigate the cost-effectiveness to facilitate wider implementation of improved organizational arrangements. Similarly, research should identify specific roadblocks to translating evidence into action. These may be structures and processes at the health system level, e.g. availability of professionals with the right skillset, reimbursement mechanisms, and clear organizational intervention implementation guidelines.

Biliary diversion increases resting energy expenditure leading to decreased blood glucose level in mice with type 2 diabetes.

AIMS/INTRODUCTION: Type 2 diabetes mellitus is a group of metabolism abnormalities in carbohydrates and energy. Our aim was to investigate resting energy expenditure (REE) and blood glucose changes after biliary diversion in mice with diabetes. MATERIALS AND METHODS: Male mice with diabetes were randomly divided into biliary diversion and sham groups. REE was detected by indirect calorimetry, the levels of fasting blood glucose, total bile acids and triiodothyronine were analyzed. After mice were killed, the weight amount of brown adipose tissue (BAT) and gastrocnemius was measured, and the expression level of G protein-coupled bile acid receptor and type 2 iodothyronine deiodinase in BAT and gastrocnemius were examined. RESULTS: The two groups of mice were pair-fed, the bodyweights (P < 0.001) and the fasting blood glucose level (P < 0.001) in the biliary diversion group significantly decreased 24 weeks after surgery. The intraperitoneal glucose tolerance test (P = 0.035) and oral glucose tolerance test (P = 0.027) showed improvement in glucose tolerance after surgery. The REE level significantly increased 24 weeks after surgery (P = 0.005), the levels of total bile acids (P = 0.014) and triiodothyronine (P < 0.001) increased at the 24th postoperative week. The weight ratio of BAT (P = 0.038) and gastrocnemius (P = 0.026) in the biliary diversion group were higher than that in the sham group. The expression of G protein-coupled bile acid receptor in BAT (P < 0.001) and gastrocnemius (P = 0.003) were upregulated after surgery, and the type 2 iodothyronine deiodinase expression also increased in BAT (P = 0.015) and gastrocnemius (P = 0.015). CONCLUSIONS: The REE level increased and the glucose metabolism improved in mice with diabetes after biliary diversion.

Sleeve gastrectomy in class 1 obesity: Assessment of operative outcomes.

BACKGROUND: The risk/benefit ratio of sleeve gastrectomy (SG), especially in patients without type 2 diabetes (T2D), is unknown for patients with class 1 obesity. OBJECTIVES: Assessment of operative outcomes of SG in class 1 obesity. SETTING: Private practice. METHODS: Candidates for a primary SG with body mass index 30-35 kg/m2 after 5 years of unsuccessful dieting were included after informed consent was obtained. Participants who did not complete 3-month follow-up and those who underwent modified SGs were excluded. Data and complications were recorded prospectively. Patients were followed up at 3, 6, and 12 months and yearly thereafter. Definition of presence and remission of T2D and insulin resistance were set according to guidelines. Effects on weight loss parameters were evaluated with Wilcoxon signed-rank test. RESULTS: Between 2012 and 2020, 143 consecutive SGs were performed in patients with class 1 obesity without conversion, leak, mortality, or a venous event. Two were lost to follow-up. In 141 participants, 2 bleedings and 1 colon perforation occurred (2.1% rate for acute life-threatening events). During a mean follow-up of 25.9 months; 1 case of functional stenosis and 4 cases of de novo symptomatic cholelithiasis clinically became evident in different patients, all requiring reoperation. Therefore a 5.6% rate of major complications were identified at 2 years. The benefit on weight loss was immediate and permanent (P < .001). T2D and insulin resistance were in remission in 100% and 98.1% of participants at 1 year, respectively. CONCLUSION: The 5.6% major complication rate reflects a minimum because more de novo symptomatic gallstones and stenosis are yet to occur or overlooked. Additionally, this excludes patients with de novo reflux and malnutrition, dissatisfaction issues, or recidivism. Caution is required to freely operate on patients with class 1 obesity with no co-morbidity. Evidence-based outcome data are lacking to balance the reported risks.

Options in Bariatric Surgery: Modeled Decision Analysis Supports One-Anastomosis Gastric Bypass as the Treatment of Choice when Type 2 Diabetes Is Present.

BACKGROUND: Obesity and type 2 diabetes mellitus (T2DM) represent significant healthcare burdens. Surgical management is superior to traditional medical therapy. Laparoscopic sleeve gastrectomy (LSG) and gastric bypass (both Roux-en-Y (RYGB) and one anastomosis gastric bypass (OAGB) are the most commonly performed metabolic procedures. It remains unclear which gives the optimal quality-of-life pay-off in the context of T2DM. This study compares LSG, RYGB, and OAGB in the management of T2DM and obesity using modeled decision analysis. Alternative approaches were assessed considering efficacy of interventions, post-operative complications, and quality of life outcomes to determine the optimal approach. METHODS: Modeled decision analysis was performed from the patent's perspective comparing best medical management (MM), SG, RYGB, OAGB, and LAGB. The base case is a 40-year-old female with a body mass index (BMI) of 40 and T2DM. Input variables were calculated based on published decision analyses and a literature review. Utilities were based on previous studies. Sensitivity analysis was performed. The payoff was quality-adjusted life years (QALYs) 5 years from intervention. TreeAge Pro modeling software was used for analysis. RESULTS: In 5-years post-procedure, OAGB gave the optimal QALY payoff of 3.65 QALYs (reviewer 2). RYGB gave 3.47, SG gave 3.08, LAGB gave 2.62 and MM 2.45 QALYs. Three input variables proved sensitive. RYGB is optimal if its metabolic improvement rates exceed 86%. It is also optimal if metabolic improvement rates in OAGB drop below 71.8% or if the utility of OAGB drops below 0.759. CONCLUSION: OAGB gives the optimal QALY payoff in treatment of T2DM. RYGB and SG also improve metabolic outcomes and remain viable options in selected patients.

Risk assessment for foot ulcers among Tunisian subjects with diabetes: a cross sectional outpatient study.

BACKGROUND: Diabetic foot is an underestimated and redoubtable diabetes complication. The aims of our study were to assess diabetic foot ulcer risk factors according to International Working Group on the Diabetic Foot (IWGDF) classification, stratify patients into risk categories and identify factors associated with higher-risk grade. METHODS: Cross-sectional setting over a period of 07 months, patients were randomly selected from the diabetic outpatients attending our unit of diabetology. Questionnaire and clinical examination were made by the same physician. Patients free of active foot ulcer were included. RESULTS: Among 230 patients evaluated, 10 had an active foot ulcer and were excluded. Five patients (2.27%) had a history of foot ulcer and 3(1.36%) had a lower-limb amputation. Sensory neuropathy, as measured by the 5.07(10 g) Semmes-Weinstein monofilament testing, was present in 23.63% of patients, whereas 36.82% had a peripheral arterial disease based on clinical findings, and 43.63% had foot deformities. According to the IWGDF classification, Group 0: 72.72%, Group 1: 5.9%, Group 2: 17.73% and Group 3: 3.63%. After univariate analysis, patients in higher-risk groups were significantly more often female, had higher age and BMI, longer diabetes duration, elevated waist circumference, low school level, retinopathy and hyperkeratosis. Multivariate logistic regression analysis identified 3 significant independent factors associated with high-risk groups: retinopathy (OR = 2.529, CI95 [1.131-5.655], p = 0.024), hyperkeratosis (OR = 2.658, CI95 [1.222-5.783], p = 0.014) and school level (OR = 0.489, CI95 [0.253-9.44], p = 0.033). CONCLUSIONS: Risk factors for foot ulceration were rather common in outpatients with diabetes. The screening of patients at risk for foot ulceration should start early, integrated with sustainable patient education.

Metabolic endoscopy: Today's science-tomorrow's treatment.

Obesity, type 2 diabetes mellitus (T2DM) and nonalcoholic steatohepatitis are increasing pandemic metabolic disorders. Lifestyle intervention (LSI) is the cornerstone treatment for these but is successful as standard care alone in only a few patients, given the modest weight loss at mid and long term. Conversely, bariatric surgery is the only proven effective treatment for these metabolic disorders, albeit offered only in a small percentage of cases because of its invasiveness and cost. The so-called endoscopic bariatric and metabolic therapies (EBMTs) include new, less-invasive technologies such as intragastric balloons, aspiration therapy, endoscopic sleeve gastroplasty, diversion devices, and duodenal mucosal resurfacing, currently at various stages of development. EBMTs, as an add-on to LSI, might represent an effective treatment filling the gap between medical and surgical management, taking into account, however, that obesity and its associated comorbidities constitute a chronic disease that needs lifelong therapy. In this review we describe the current scientific evidence surrounding EBMTs as well as future opportunities for such treatments in managing obesity and metabolic disorders.

Osteomyelitis Increases the Rate of Amputation in Patients With Type 2 Diabetes and Lower Extremity Burns.

In patients with diabetes mellitus (DM), amputation rates exceed 30% when lower extremity osteomyelitis is present. We sought to determine the rate of osteomyelitis and any subsequent amputation in our patients with DM and lower extremity burns. We performed a single-site, retrospective review at our burn center using the institutional burn center registry, linked to clinical and administrative data. Adults (≥18 years old) with DM admitted from January 1, 2014 to December 31, 2018 for isolated lower extremity burns were eligible for inclusion. We evaluated demographics, burn characteristics, comorbidities, presence of radiologically confirmed osteomyelitis, length of stay (LOS), inpatient hospitalization costs, and amputation rate at 3 months and 12 months after injury. We identified 103 patients with DM and isolated lower extremity burns. Of these, 88 patients did not have osteomyelitis, while 15 patients had radiologically confirmed osteomyelitis within 3 months of the burn injury. Compared to patients without osteomyelitis, patients with osteomyelitis had significantly increased LOS (average LOS 22.7 days vs 12.1 days, P = .0042), inpatient hospitalization costs (average $135,345 vs $62,237, P = .0008), amputation rate within 3 months (66.7% vs 5.70%, P < .00001), and amputation rate within 12 months (66.7% vs 9.1%, P < .0001). The two groups were otherwise similar in demographics, burn injury characteristics, access to healthcare, and preexisting comorbidities. Patients with DM and lower extremity burns incurred increased LOS, higher inpatient hospitalization costs, and increased amputation rates if radiologically confirmed osteomyelitis was present within 3 months of the burn injury.