Bariatric Surgery versus Intensive Medical Therapy for Diabetes — 3-Year Outcomes
Open accessAbstract
BACKGROUND: In short-term randomized trials (duration, 1 to 2 years), bariatric surgery has been associated with improvement in type 2 diabetes mellitus. METHODS: We assessed outcomes 3 years after the randomization of 150 obese patients with uncontrolled type 2 diabetes to receive either intensive medical therapy alone or intensive medical therapy plus Roux-en-Y gastric bypass or sleeve gastrectomy. The primary end point was a glycated hemoglobin level of 6.0% or less. RESULTS: The mean (±SD) age of the patients at baseline was 48±8 years, 68% were women, the mean baseline glycated hemoglobin level was 9.3±1.5%, and the mean baseline body-mass index (the weight in kilograms divided by the square of the height in meters) was 36.0±3.5. A total of 91% of the patients completed 36 months of follow-up. At 3 years, the criterion for the primary end point was met by 5% of the patients in the medical-therapy group, as compared with 38% of those in the gastric-bypass group (P<0.001) and 24% of those in the sleeve-gastrectomy group (P=0.01). The use of glucose-lowering medications, including insulin, was lower in the surgical groups than in the medical-therapy group. Patients in the surgical groups had greater mean percentage reductions in weight from baseline, with reductions of 24.5±9.1% in the gastric-bypass group and 21.1±8.9% in the sleeve-gastrectomy group, as compared with a reduction of 4.2±8.3% in the medical-therapy group (P<0.001 for both comparisons). Quality-of-life measures were significantly better in the two surgical groups than in the medical-therapy group. There were no major late surgical complications. CONCLUSIONS: Among obese patients with uncontrolled type 2 diabetes, 3 years of intensive medical therapy plus bariatric surgery resulted in glycemic control in significantly more patients than did medical therapy alone. Analyses of secondary end points, including body weight, use of glucose-lowering medications, and quality of life, also showed favorable results at 3 years in the surgical groups, as compared with the group receiving medical therapy alone. (Funded by Ethicon and others; STAMPEDE ClinicalTrials.gov number, NCT00432809.).
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MNT education by registered dieticians is effective.
“MNT education by registered dieticians is effective 10 , 11 (grade A: 95% agreement).”
From Japanese clinical practice guideline for diabetes 2019 (2020) · cites this paper as [11]
Blood pressure control is useful for suppressing the onset/progression of diabetic retinopathy in patients with type 2 diabetes.
“Blood pressure control has been shown to be useful for suppressing the onset/progression of diabetic retinopathy in patients with type 2 diabetes 9 , 10 , 11 (grade A: 100% agreement).”
From Japanese clinical practice guideline for diabetes 2019 (2020) · cites this paper as [11]
SMBG is useful for patients with type 1 diabetes.
“SMBG has been shown to be useful for patients with type 1 diabetes 9 , 10 , 11 and for patients with type 2 diabetes receiving insulin therapy 12 (grade A: 95% agreement).”
From Japanese clinical practice guideline for diabetes 2019 (2020) · cites this paper as [11]
Blood pressure control is effective in inhibiting the onset/progression of diabetic nephropathy.
“Blood pressure control is shown to be effective in inhibiting the onset/progression of diabetic nephropathy 11 , 12 , 13 (grade A: 100% agreement).”
From Japanese clinical practice guideline for diabetes 2019 (2020) · cites this paper as [11]
Tight glycemic control, initiated early after the onset of diabetes, is effective in suppressing the risk of diabetic macroangiopathy.
“Tight glycemic control, initiated early after the onset of diabetes, has been shown to be effective in suppressing the risk of diabetic macroangiopathy 10 , 11 (grade A: 95% agreement).”
From Japanese clinical practice guideline for diabetes 2019 (2020) · cites this paper as [11]
If appropriate perioperative support and safety are ensured, surgical therapy for obesity is effective in patients with type 2 diabetes and high-degree obesity who have difficulty losing weight.
“If appropriate perioperative support and safety are ensured, surgical therapy for obesity is shown to be effective in patients with type 2 diabetes and high‐degree obesity who have difficulty losing weight 11 , 12 , 13 , 14 (grade B: 90% agreement).”
From Japanese clinical practice guideline for diabetes 2019 (2020) · cites this paper as [11]
The use of statins reduces the risk of cardiovascular disease and mortality in patients with diabetes and dyslipidemia.
“The use of statins has been shown to reduce the risk of CVD and mortality in patients with diabetes and dyslipidemia 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 (grade A: 100% agreement).”
From Japanese clinical practice guideline for diabetes 2019 (2020) · cites this paper as [11]
Weight loss surgery markedly reduces the risk of type 2 diabetes in highly obese individuals.
“Weight loss surgery markedly reduces the risk of type 2 diabetes in highly obese individuals 11 .”
From Japanese clinical practice guideline for diabetes 2019 (2020) · cites this paper as [11]
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- Authors
- Schauer, P. R., Bhatt, D. L., Kirwan, J. P., Wolski, K., Brethauer, S. A., Navaneethan, S. D., Aminian, A., Pothier, C. E., Kim, E. S. H., Nissen, S. E., & Kashyap, S. R.
- Affiliations
- Brigham and Women's Hospital (US)
- Cleveland Clinic (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2014-05-22
- Volume
- 370
- Issue
- 21
- Pages
- 2002-2013
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC5451259
- OpenAlex
- W2147872784
- Cited by
- 1,901
- References
- 28
- Citations by year
- 2026: 35 · 2025: 56 · 2024: 83 · 2023: 117 · 2022: 105 · 2021: 157 · 2020: 157 · 2019: 146 · 2018: 206 · 2017: 243 · 2016: 243 · 2015: 236 · 2014: 107 · 2013: 3 · 2012: 2
- FWCI
- 273.84
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- Amgen
- Bristol-Myers Squibb
- Eli Lilly and Company
- Pfizer
- AstraZeneca
- Sanofi
- Cleveland Clinic
- Stryker
- Amarin Corporation
- Anthera
- Medicines Company
- Regado Biosciences
- Eisai
- Novo Nordisk
- National Institutes of Health
- Cereal Partners Worldwide
- 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
- bariatric surgery, type 2 diabetes, Roux-en-Y gastric bypass, sleeve gastrectomy, intensive medical therapy, glycemic control, HbA1c, obesity, weight loss, glucose-lowering medications, insulin use, quality of life, long-term outcomes, STAMPEDE trial, randomized controlled trials, surgical complications, body mass index
- MeSH terms
- Adult, Combined Modality Therapy, Diabetes Mellitus, Type 2, Female, Follow-Up Studies, Gastrectomy, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Cholesterol, LDL, Male, Middle Aged, Obesity, Postoperative Complications, Quality of Life, Triglycerides, Gastric Bypass, Biomarkers, Weight Loss, Body Mass Index
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