Dataset Information

Long-term Microvascular Disease Outcomes in Patients With Type 2 Diabetes After Bariatric Surgery: Evidence for the Legacy Effect of Surgery.

ABSTRACT:

Objective

To identify and quantify any legacy effect of bariatric surgery on risk of incident microvascular disease in patients with type 2 diabetes.

Research design and methods

We conducted a retrospective observational cohort study (n = 4,683; 40% racial/ethnic minority) of patients with type 2 diabetes who underwent bariatric surgery from 2001 through 2011. The primary outcome measure was incident microvascular disease defined as a composite indicator of the first occurrence of retinopathy, neuropathy, and/or nephropathy. The Cox proportional hazards framework was used to investigate the associations between type 2 diabetes remission/relapse status and time to microvascular disease.

Results

Covariate-adjusted analyses showed that patients who experienced type 2 diabetes remission had 29% lower risk of incident microvascular disease compared with patients who never remitted (hazard ratio [HR] 0.71 [95% CI 0.60, 0.85]). Among patients who experienced a relapse after remission, the length of time spent in remission was inversely related to the risk of incident microvascular disease; for every additional year of time spent in remission prior to relapse, the risk of microvascular disease was reduced by 19% (HR 0.81 [95% CI 0.67, 0.99]) compared with patients who never remitted.

Conclusions

Our results indicate that remission of type 2 diabetes after bariatric surgery confers benefits for risk of incident microvascular disease even if patients eventually experience a relapse of their type 2 diabetes. This provides support for a legacy effect of bariatric surgery, where even a transient period of surgically induced type 2 diabetes remission is associated with lower long-term microvascular disease risk.

SUBMITTER: Coleman KJ

PROVIDER: S-EPMC4955928 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature

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Publications

Long-term Microvascular Disease Outcomes in Patients With Type 2 Diabetes After Bariatric Surgery: Evidence for the Legacy Effect of Surgery.

Coleman Karen J KJ Haneuse Sebastien S Johnson Eric E Bogart Andy A Fisher David D O'Connor Patrick J PJ Sherwood Nancy E NE Sidney Steve S Theis Mary Kay MK Anau Jane J Schroeder Emily B EB O'Brien Rebecca R Arterburn David D

Diabetes care 20160606 8

<h4>Objective</h4>To identify and quantify any legacy effect of bariatric surgery on risk of incident microvascular disease in patients with type 2 diabetes.<h4>Research design and methods</h4>We conducted a retrospective observational cohort study (n = 4,683; 40% racial/ethnic minority) of patients with type 2 diabetes who underwent bariatric surgery from 2001 through 2011. The primary outcome measure was incident microvascular disease defined as a composite indicator of the first occurrence of ...[more]

PMID: 27271192

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Project description:ImportanceRandomized clinical trials of bariatric surgery have been limited in size, type of surgical procedure, and follow-up duration.ObjectiveTo determine long-term glycemic control and safety of bariatric surgery compared with medical/lifestyle management of type 2 diabetes.Design, setting, and participantsARMMS-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.InterventionParticipants 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 measuresThe primary outcome was change in hemoglobin A1c (HbA1c) from baseline to 7 years for all participants. Data are reported for up to 12 years.ResultsA 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 relevanceAfter 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 registrationClinicalTrials.gov Identifier: NCT02328599.

Project description:The clinical evidence base demonstrating bariatric surgery's health benefits is much larger than it was when the National Institutes of Health last held a consensus panel in 1991. Still, it remains unclear whether ongoing studies will address critical questions about long-term complication rates and the sustainability of weight loss and comorbidity control.To summarize findings from a multidisciplinary workshop convened in May 2013 by the National Institute of Diabetes and Digestive and Kidney Diseases and the National Heart, Lung, and Blood Institute. The workshop aimed to summarize the current state of knowledge of bariatric surgery, review research findings on the long-term outcomes of bariatric surgery, and establish priorities for future research directions.The evidence presented at the workshop was selected by the planning committee for both its quality and duration of follow-up. The data review emphasized randomized clinical trials and large observational studies with long-term follow-up, with or without a control group.Several small randomized clinical trials showed greater weight loss and type 2 diabetes mellitus remission compared with nonsurgical treatments within the first 2 years of follow-up after bariatric surgery. Large, long-term observational studies have shown durable (>5 years) weight loss, diabetes, and lipid improvements with bariatric surgery. Still unclear are predictors of outcomes, long-term complications, long-term survival, microvascular and macrovascular events, mental health outcomes, and costs. The studies needed to address these knowledge gaps would be expensive and logistically difficult to perform.High-quality evidence shows that bariatric surgical procedures result in greater weight loss than nonsurgical treatments and are more effective at inducing initial type 2 diabetes mellitus remission in obese patients. More information is needed about the long-term durability of comorbidity control and complications after bariatric procedures and this evidence will most likely come from carefully designed observational studies.

Project description:BackgroundBariatric 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 .ObjectiveWe 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.MethodsUsing 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 ).ResultsThe 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).ConclusionsDiabetes 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.

Project description:BackgroundBariatric surgery improves glycemic control in patients with type 2 diabetes mellitus (T2DM), but less is known about microvascular outcomes.ObjectiveTo investigate the relationship between bariatric surgery and incident microvascular complications of T2DM.DesignRetrospective matched cohort study from 2005 to 2011 with follow-up through September 2015.Setting4 integrated health systems in the United States.ParticipantsPatients aged 19 to 79 years with T2DM who had bariatric surgery (n = 4024) were matched on age, sex, body mass index, hemoglobin A1c level, insulin use, diabetes duration, and intensity of health care use up to 3 nonsurgical participants (n = 11 059).InterventionBariatric procedures (76% gastric bypass, 17% sleeve gastrectomy, and 7% adjustable gastric banding) compared with usual care.MeasurementsAdjusted Cox regression analysis investigated time to incident microvascular disease, defined as first occurrence of diabetic retinopathy, neuropathy, or nephropathy.ResultsMedian follow-up was 4.3 years for both surgical and nonsurgical patients. Bariatric surgery was associated with significantly lower risk for incident microvascular disease at 5 years (16.9% for surgical vs. 34.7% for nonsurgical patients; adjusted hazard ratio [HR], 0.41 [95% CI, 0.34 to 0.48]). Bariatric surgery was associated with lower cumulative incidence at 5 years of diabetic neuropathy (7.2% for surgical vs. 21.4% for nonsurgical patients; HR, 0.37 [CI, 0.30 to 0.47]), nephropathy (4.9% for surgical vs. 10.0% for nonsurgical patients; HR, 0.41 [CI, 0.29 to 0.58]), and retinopathy (7.2% for surgical vs. 11.2% for nonsurgical patients; HR, 0.55 [CI, 0.42 to 0.73]).LimitationElectronic health record databases could misclassify microvascular disease status for some patients.ConclusionIn this large, multicenter study of adults with T2DM, bariatric surgery was associated with lower overall incidence of microvascular disease (including lower risk for neuropathy, nephropathy, and retinopathy) than usual care.Primary funding sourceNational Institute of Diabetes and Digestive and Kidney Diseases.

Dataset Information

Long-term Microvascular Disease Outcomes in Patients With Type 2 Diabetes After Bariatric Surgery: Evidence for the Legacy Effect of Surgery.

Objective

Research design and methods

Results

Conclusions

Publications

Long-term Microvascular Disease Outcomes in Patients With Type 2 Diabetes After Bariatric Surgery: Evidence for the Legacy Effect of Surgery.

Similar Datasets

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