Bariatric Surgery versus Intensive Medical Therapy for Diabetes — 5-Year Outcomes
Open accessAbstract
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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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 measuredMBS 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 measuredExpected 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 measuredSeveral 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.”
In people with type 2 diabetes, surgical weight loss proved more effective than pharmacotherapy in reducing or even resolving hyperglycemia and was further associated with a reduction in microvascular and macrovascular complications.
“In people with type 2 diabetes, surgical weight loss proved more effective than pharmacotherapy in reducing or even resolving hyperglycemia [90] and was further associated with a reduction in microvascular and macrovascular complications [91].”
From Obesity and MASLD: Is weight loss the (only) key to treat metabolic liver disease? (2024) · cites this paper as [90]
Metabolic surgery, especially Roux-en-Y gastric bypass and sleeve gastrectomy, are very effective interventions to achieve both weight and glycemic goals and have additional health benefits beyond improving metabolism.
“Metabolic surgery, especially Roux-en-Y gastric bypass and sleeve gastrectomy, are very effective interventions to achieve both weight and glycemic goals and have additional health benefits beyond improving metabolism (162).”
From 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes—2025 (2025) · cites this paper as [162]
The first dedicated kidney outcome trial with a GLP-1RA (injectable semaglutide) demonstrated benefit in reducing major kidney disease events.
“The first dedicated kidney outcome trial with a GLP-1RA (injectable semaglutide) demonstrated benefit in reducing major kidney disease events.110”
From Diagnosis and Treatment of Type 2 Diabetes in Adults (2025) · cites this paper as [110]
The Methods (Trial Outcomes; page unavailable) describe a bariatric-surgery-versus-medical-therapy trial whose primary outcome was glycemic control. The Results (Renal Outcomes; page unavailable) report albumin-to-creatinine ratios, not major kidney disease events from a semaglutide trial. Searches for injectable semaglutide, GLP-1 receptor agonists, and a dedicated kidney outcome trial found no passage addressing the claim. (LLM, conf=0.78)
Experimental — accuracy not yet measuredThe larger evidence base for surgical outcomes compared with AOMs may have shaped clinical preferences.
“The larger body of evidence supporting surgical outcomes compared to AOMs may have influenced clinical preferences (31–33).”
From Regional trends and disparities in newer <scp>GLP1</scp> receptor agonist initiation among real‐world adult patients eligible for obesity treatment (2025) · cites this paper as [33]
Clinical trials of bariatric surgery in patients with type 2 diabetes have consistently shown improvement in cardiovascular risk factors, including better glycemic control, lower blood pressure, higher high-density lipoprotein cholesterol, and lower triglyceride levels.
“clinical trials of bariatric surgery in patients with T2DM have consistently shown improvement in cardiovascular risk factors, including better glycemic control, lower blood pressure, higher high-density lipoprotein cholesterol, and lower triglyceride levels”
From Clinical management of stable coronary artery disease in patients with type 2 diabetes mellitus: a scientific statement from the American Heart Association (2020) · cites this paper as [175]
Fifteen RCTs were identified comparing weight loss after bariatric surgery or medical therapy.
“Fifteen RCTs were identified comparing weight loss after bariatric surgery or medical therapy (5 reporting on RYGB, 3 on LAGB and the rest on mixed patient populations undergoing sleeve gastrectomy, BPD/DS, sleeve gastrectomy and/or banding) [21–35].”
In an extension of a semaglutide 2.4 mg trial, participants lost 17.3% of initial weight; discontinuation of the drug and associated lifestyle intervention led to regain of two-thirds of the lost weight in the ensuing year, with similar reversion in improvements of cardiometabolic variables.
“in an extension of a clinical trial of semaglutide 2.4mg in which participants lost 17.3% of their initial weight, discontinuation of the drug and associated lifestyle intervention led to regain of two-thirds of the lost weight in the ensuing year, with similar reversion in improvements of cardiometabolic variables.98”
From Approach to Obesity Treatment in Primary Care: A Review (2024) · cites this paper as [98]
Visceral adipose tissue reduction following bariatric surgery rapidly decreases blood pressure.
“VAT reduction following bariatric surgery (for example, vertical sleeve gastrectomy or Roux-en-Y gastric bypass) rapidly decreases BP16,17.”
From Obesity, kidney dysfunction and hypertension: mechanistic links (2019) · cites this paper as [17]
Bariatric surgery is superior to medical/lifestyle interventions in the maintenance of weight loss and the remission of diabetes and dyslipidemia.
“Data from short- and long-term studies corroborate the superiority of bariatric surgery compared with medical/lifestyle interventions in the maintenance of weight loss and the remission of diabetes and dyslipidemia [117, 118].”
From Bariatric surgery: remission of inflammation, cardiometabolic benefits, and common adverse effects (2020) · cites this paper as [118]
This distinction may be a central reason for the wide difference in long-term weight loss response rates between negative energy balance approaches and bariatric surgery procedures.
“Indeed, this may be a central reason for the wide difference seen in long-term weight loss response rates between negative energy balance approaches and bariatric surgery procedures [117, 118].”
From Bariatric surgery: remission of inflammation, cardiometabolic benefits, and common adverse effects (2020) · cites this paper as [118]
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“64 68 Both options involve close oversight and are unlikely to be scalable at a population level globally.”
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Self-citationAminian, A., Zajichek, A., Tu, C., Wolski, K. E., Brethauer, S. A., Schauer, P. R., Kattan, M. W., & Nissen, S. E. (2020) · Annals of Surgery · doi:10.1097/sla.0000000000004369 · Cited by 52 · see citing works
Self-citationDiabetes after Bariatric Surgery
Shah, A., & Laferrère, B. (2017) · Canadian Journal of Diabetes · doi:10.1016/j.jcjd.2016.12.009 · Cited by 50 · see citing works
- 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)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2017-02-16
- Volume
- 376
- Issue
- 7
- Pages
- 641-651
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC5451258
- 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
- bronze
- doi.org
- 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
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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