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Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes
Open accessAbstract
BACKGROUND: Observational studies have shown improvement in patients with type 2 diabetes mellitus after bariatric surgery. METHODS: In this randomized, nonblinded, single-center trial, we evaluated the efficacy of intensive medical therapy alone versus medical therapy plus Roux-en-Y gastric bypass or sleeve gastrectomy in 150 obese patients with uncontrolled type 2 diabetes. The mean (±SD) age of the patients was 49±8 years, and 66% were women. The average glycated hemoglobin level was 9.2±1.5%. The primary end point was the proportion of patients with a glycated hemoglobin level of 6.0% or less 12 months after treatment. RESULTS: Of the 150 patients, 93% completed 12 months of follow-up. The proportion of patients with the primary end point was 12% (5 of 41 patients) in the medical-therapy group versus 42% (21 of 50 patients) in the gastric-bypass group (P=0.002) and 37% (18 of 49 patients) in the sleeve-gastrectomy group (P=0.008). Glycemic control improved in all three groups, with a mean glycated hemoglobin level of 7.5±1.8% in the medical-therapy group, 6.4±0.9% in the gastric-bypass group (P<0.001), and 6.6±1.0% in the sleeve-gastrectomy group (P=0.003). Weight loss was greater in the gastric-bypass group and sleeve-gastrectomy group (-29.4±9.0 kg and -25.1±8.5 kg, respectively) than in the medical-therapy group (-5.4±8.0 kg) (P<0.001 for both comparisons). The use of drugs to lower glucose, lipid, and blood-pressure levels decreased significantly after both surgical procedures but increased in patients receiving medical therapy only. The index for homeostasis model assessment of insulin resistance (HOMA-IR) improved significantly after bariatric surgery. Four patients underwent reoperation. There were no deaths or life-threatening complications. CONCLUSIONS: In obese patients with uncontrolled type 2 diabetes, 12 months of medical therapy plus bariatric surgery achieved glycemic control in significantly more patients than medical therapy alone. Further study will be necessary to assess the durability of these results. (Funded by Ethicon Endo-Surgery and others; ClinicalTrials.gov number, NCT00432809.).
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In the citing paper
“The complication evidence base included those studies from the efficacy and predictors searches that included complication data,141,156 as well as those studies that met the expanded search criteria.139,143,145,146,152,153,160,170,171”
In the citing paper
“Given the modest efficacy of currently approved pharmacotherapies, [7][8][9] semaglutide may offer the potential to bridge the gap between behavioral and pharmacological options and bariatric surgery, which is currently considered the most effective and reliable intervention available for weight management.6,27,32”
In the citing paper
“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 the citing paper
“Bariatric surgery is an effective and increasingly common treatment for severe obesity and its many co-morbidities.”
From Bone loss after bariatric surgery: causes, consequences, and management (2014) · cites this paper as [4]
In the citing paper
“As such, the gold standard in weight loss therapy has long been bariatric surgery, which routinely achieves 25% to 30% loss (71).”
From GLP-1 and the Neurobiology of Eating Control: Recent Advances (2025) · cites this paper as [71]
In the citing paper
“Prior to the 2014 approval of 3-mg liraglutide for this indication (70), most AOMs barely achieved the ≥ 5% threshold for clinically meaningful weight loss (71‐73).”
From GLP-1 and the Neurobiology of Eating Control: Recent Advances (2025) · cites this paper as [71]
In the citing paper
“bariatric procedures can have immediate effects in lowering blood sugar levels in diabetes prior to evident changes of body weight [4], [5]”
From Treatment of obesity and diabetes using oxytocin or analogs in patients and mouse models (2013) · cites this paper as [4]
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Metadata
- Authors
- Schauer, P. R., Kashyap, S. R., Wolski, K., Brethauer, S. A., Kirwan, J. P., Pothier, C. E., Thomas, S., Abood, B., Nissen, S. E., & Bhatt, D. L.
- Affiliations
- Cleveland Clinic (US)
- Brigham and Women's Hospital (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2012-04-26
- Volume
- 366
- Issue
- 17
- Pages
- 1567-1576
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC3372918
- OpenAlex
- W2105725047
- Cited by
- 2,164
- References
- 22
- Citations by year
- 2026: 43 · 2025: 58 · 2024: 80 · 2023: 90 · 2022: 108 · 2021: 123 · 2020: 139 · 2019: 121 · 2018: 122 · 2017: 164 · 2016: 175 · 2015: 273 · 2014: 263 · 2013: 271 · 2012: 129
- FWCI
- 305.66
- 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
- Bristol-Myers Squibb
- Sanofi
- Brigham and Women's Hospital
- Cleveland Clinic
- Boston VA Research Institute
- Intuitive Surgical
- Amarin Corporation
- Medicines Company
- Eisai
- Allergan
- National Institute of Diabetes and Digestive and Kidney Diseases (R01DK089547)
- Ethicon Endo-Surgery
- 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, obesity, Roux-en-Y gastric bypass, sleeve gastrectomy, intensive medical therapy, glycemic control, HbA1c, weight loss, insulin resistance, HOMA-IR, antidiabetic drug use, reoperation, diabetes remission, metabolic surgery, lifestyle modification
- MeSH terms
- Adult, Cholesterol, Combined Modality Therapy, Diabetes Mellitus, Type 2, Female, Follow-Up Studies, Gastrectomy, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Male, Middle Aged, Obesity, Postoperative Complications, Gastric Bypass, Weight Loss, Body Mass Index, Metabolic Syndrome
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