Cited by 2,934Bariatric Surgery and OutcomesDiabetes Treatment and ManagementDiabetes, Cardiovascular Risks, and Lipoproteins

Bariatric Surgery versus Intensive Medical Therapy for Diabetes — 5-Year Outcomes

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Schauer, Philip R., Bhatt, Deepak L., Kirwan, John P., Wolski, Kathy, Aminian, Ali, Brethauer, Stacy A., Navaneethan, Sankar D., Singh, Rishi P. +3 more·2017·New England Journal of Medicine

Abstract

BACKGROUND: Long-term results from randomized, controlled trials that compare medical therapy with surgical therapy in patients with type 2 diabetes are limited. METHODS: We assessed outcomes 5 years after 150 patients who had type 2 diabetes and a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of 27 to 43 were randomly assigned to receive intensive medical therapy alone or intensive medical therapy plus Roux-en-Y gastric bypass or sleeve gastrectomy. The primary outcome was a glycated hemoglobin level of 6.0% or less with or without the use of diabetes medications. RESULTS: Of the 150 patients who underwent randomization, 1 patient died during the 5-year follow-up period; 134 of the remaining 149 patients (90%) completed 5 years of follow-up. At baseline, the mean (±SD) age of the 134 patients was 49±8 years, 66% were women, the mean glycated hemoglobin level was 9.2±1.5%, and the mean BMI was 37±3.5. At 5 years, the criterion for the primary end point was met by 2 of 38 patients (5%) who received medical therapy alone, as compared with 14 of 49 patients (29%) who underwent gastric bypass (unadjusted P=0.01, adjusted P=0.03, P=0.08 in the intention-to-treat analysis) and 11 of 47 patients (23%) who underwent sleeve gastrectomy (unadjusted P=0.03, adjusted P=0.07, P=0.17 in the intention-to-treat analysis). Patients who underwent surgical procedures had a greater mean percentage reduction from baseline in glycated hemoglobin level than did patients who received medical therapy alone (2.1% vs. 0.3%, P=0.003). At 5 years, changes from baseline observed in the gastric-bypass and sleeve-gastrectomy groups were superior to the changes seen in the medical-therapy group with respect to body weight (-23%, -19%, and -5% in the gastric-bypass, sleeve-gastrectomy, and medical-therapy groups, respectively), triglyceride level (-40%, -29%, and -8%), high-density lipoprotein cholesterol level (32%, 30%, and 7%), use of insulin (-35%, -34%, and -13%), and quality-of-life measures (general health score increases of 17, 16, and 0.3; scores on the RAND 36-Item Health Survey ranged from 0 to 100, with higher scores indicating better health) (P<0.05 for all comparisons). No major late surgical complications were reported except for one reoperation. CONCLUSIONS: Five-year outcome data showed that, among patients with type 2 diabetes and a BMI of 27 to 43, bariatric surgery plus intensive medical therapy was more effective than intensive medical therapy alone in decreasing, or in some cases resolving, hyperglycemia. (Funded by Ethicon Endo-Surgery and others; STAMPEDE ClinicalTrials.gov number, NCT00432809 .).

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Crossref · 10.1056/nejmoa1600869

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  • Recidivism in glycemia is typically observed across all interventions in diabetes, including pharmaceutical interventions.

    “Although recidivism in glycemia is typically observed across all interventions in diabetes [4,5,6,29] including pharmaceutical interventions [3,37]”

    From 5-Year effects of a novel continuous remote care model with carbohydrate-restricted nutrition therapy including nutritional ketosis in type 2 diabetes: An extension study (2024) · cites this paper as [4]

    The Results (Primary End Point; page not provided) describe relapse of glycemic control across the trial’s groups, which included intensive medical therapy and two surgical procedures. That supports relapse occurring under these interventions, but this trial does not establish that it is typically observed across all diabetes interventions. (LLM, conf=0.84)

    Experimental — accuracy not yet measured
  • MBS is proven superior to diet, exercise, and other lifestyle interventions in attaining significant and durable weight loss and improving obesity-related co-morbid conditions.

    “MBS is proven superior to diet, exercise, and other lifestyle interventions in attaining significant and durable weight loss, and improving obesity-related co-morbid conditions in multiple observational and prospective studies [9, 32, 116].”

    From 2022 American Society of Metabolic and Bariatric Surgery (ASMBS) and International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) Indications for Metabolic and Bariatric Surgery (2023) · cites this paper as [32]

    The Results (Weight Loss and Glycemic Control; page unavailable) report greater, sustained weight and glycemic improvements after surgery over five years. But the trial compared surgery plus intensive medical therapy with intensive medical therapy alone in patients with type 2 diabetes and BMI 27–43—not with diet or exercise alone. The Discussion (page unavailable) also says that benefits for clinical outcomes such as stroke or renal failure remain unestablished. (LLM, conf=0.86)

    Experimental — accuracy not yet measured
  • Expected benefits of metabolic surgery include improved quality of life, reduced cardiovascular events, and decreased risk of hepatocellular, colorectal, pancreatic, gallbladder, breast, endometrial, and ovarian cancers.

    “In addition to weight reduction and decreased glycemia (with diabetes remission in some patients), expected benefits of metabolic surgery include improved quality of life, reduced cardiovascular events, and decreased risk of hepatocellular, colorectal, pancreatic, gallbladder, breast, endometrial, and ovarian cancers.14,123–126”

    From Diagnosis and Treatment of Type 2 Diabetes in Adults (2025) · cites this paper as [123]

    The Results (Quality of Life) and Discussion report better quality-of-life outcomes after surgery than after medical therapy at five years. The Discussion says the trial was too small and short to detect differences in cardiovascular events; it does not establish a reduction in those events. Our copy does not address risk reductions for the listed cancers. (LLM, conf=0.90)

    Experimental — accuracy not yet measured
  • Several approaches have been reported to elicit T2D remission including surgery, intensive insulin therapy upon diagnosis, and nutrition therapy utilizing significant caloric and/or dietary carbohydrate restriction.

    “Several approaches have been reported to elicit T2D remission including surgery, intensive insulin therapy upon diagnosis, and nutrition therapy utilizing significant caloric and/or dietary carbohydrate restriction [4][5][6][7].”
  • MBS yields superior diabetes improvement and weight loss in randomized controlled trials that include the subset of patients with BMI <35 kg/m2.

    “Ikramuddin et al. [31] and Schauer et al. [32] demonstrated superior diabetes improvement and weight loss following MBS in randomized controlled trials that include the subset of patients with BMI <35 kg/m2.”

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Authors
Schauer, P. R., Bhatt, D. L., Kirwan, J. P., Wolski, K., Aminian, A., Brethauer, S. A., Navaneethan, S. D., Singh, R. P., Pothier, C. E., Nissen, S. E., & Kashyap, S. R.
Affiliations
Brigham and Women's Hospital (US)
Venue
New England Journal of Medicine
Published
2017-02-16
Volume
376
Issue
7
Pages
641-651
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W2915948028
Cited by
2,934
References
50
Citations by year
2026: 243 · 2025: 253 · 2024: 265 · 2023: 278 · 2022: 300 · 2021: 364 · 2020: 370 · 2019: 313 · 2018: 287 · 2017: 172 · 2016: 53 · 2015: 32 · 2014: 1
FWCI
320.03
Type
journal article
Language
en
Open access
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion)
Funders
National Institute of Diabetes and Digestive and Kidney Diseases (R01DK089547)
Topics
  • Health Sciences › Medicine › Surgery › Bariatric Surgery and Outcomes
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
Keywords
type 2 diabetes, bariatric surgery, Roux-en-Y gastric bypass, sleeve gastrectomy, intensive medical therapy, HbA1c, long-term outcomes, weight loss, insulin requirement, triglycerides, HDL cholesterol, obesity, diabetes remission, weight loss maintenance, randomized controlled trials, intention-to-treat analysis, five-year follow-up
MeSH terms
Adult, Blood Glucose, Combined Modality Therapy, Diabetes Mellitus, Type 2, Female, Gastrectomy, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Insulin, Cholesterol, HDL, Male, Middle Aged, Obesity, Triglycerides, Gastric Bypass, Body Mass Index, Treatment Outcome

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