Roux-en-Y Gastric Bypass vs Intensive Medical Management for the Control of Type 2 Diabetes, Hypertension, and Hyperlipidemia: The Diabetes Surgery Study Randomized Clinical Trial
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IMPORTANCE: Controlling glycemia, blood pressure, and cholesterol is important for patients with diabetes. How best to achieve this goal is unknown. OBJECTIVE: To compare Roux-en-Y gastric bypass with lifestyle and intensive medical management to achieve control of comorbid risk factors. DESIGN, SETTING, AND PARTICIPANTS: A 12-month, 2-group unblinded randomized trial at 4 teaching hospitals in the United States and Taiwan involving 120 participants who had a hemoglobin A1c (HbA1c) level of 8.0% or higher, body mass index (BMI) between 30.0 and 39.9, C peptide level of more than 1.0 ng/mL, and type 2 diabetes for at least 6 months. The study began in April 2008. INTERVENTIONS: Lifestyle-intensive medical management intervention and Roux-en-Y gastric bypass surgery. Medications for hyperglycemia, hypertension, and dyslipidemia were prescribed according to protocol and surgical techniques that were standardized. MAIN OUTCOMES AND MEASURES: Composite goal of HbA1c less than 7.0%, low-density lipoprotein cholesterol less than 100 mg/dL, and systolic blood pressure less than 130 mm Hg. RESULTS: All 120 patients received the intensive lifestyle-medical management protocol and 60 were randomly assigned to undergo Roux-en-Y gastric bypass. After 12-months, 28 participants (49%; 95% CI, 36%-63%) in the gastric bypass group and 11 (19%; 95% CI, 10%-32%) in the lifestyle-medical management group achieved the primary end points (odds ratio [OR], 4.8; 95% CI, 1.9-11.7). Participants in the gastric bypass group required 3.0 fewer medications (mean, 1.7 vs 4.8; 95% CI for the difference, 2.3-3.6) and lost 26.1% vs 7.9% of their initial body weigh compared with the lifestyle-medical management group (difference, 17.5%; 95% CI, 14.2%-20.7%). Regression analyses indicated that achieving the composite end point was primarily attributable to weight loss. There were 22 serious adverse events in the gastric bypass group, including 1 cardiovascular event, and 15 in the lifestyle-medical management group. There were 4 perioperative complications and 6 late postoperative complications. The gastric bypass group experienced more nutritional deficiency than the lifestyle-medical management group. CONCLUSIONS AND RELEVANCE: In mild to moderately obese patients with type 2 diabetes, adding gastric bypass surgery to lifestyle and medical management was associated with a greater likelihood of achieving the composite goal. Potential benefits of adding gastric bypass surgery to the best lifestyle and medical management strategies of diabetes must be weighed against the risk of serious adverse events. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00641251.
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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].”
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Jahansouz, C., Serrot, F. J., Frohnert, B. I., Foncea, R. E., Dorman, R. B., Slusarek, B., Leslie, D. B., Bernlohr, D. A., & Ikramuddin, S. (2015) · Obesity Surgery · doi:10.1007/s11695-015-1708-5 · Cited by 32 · see citing works
Self-citationHorwitz, D., Saunders, J. K., Ude-Welcome, A., Marie Schmidt, A., Dunn, V., Leon Pachter, H., & Parikh, M. (2016) · Surgery for Obesity and Related Diseases · doi:10.1016/j.soard.2016.01.016 · Cited by 30 · see citing works
Urinary sodium excretion after gastric bypass surgery
Docherty, N. G., Fändriks, L., le Roux, C. W., Hallersund, P., & Werling, M. (2017) · Surgery for Obesity and Related Diseases · doi:10.1016/j.soard.2017.04.002 · Cited by 22 · see citing works
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- Authors
- Ikramuddin, S., Korner, J., Lee, W.-J., Connett, J. E., Inabnet, W. B., Billington, C. J., Thomas, A. J., Leslie, D. B., Chong, K., Jeffery, R. W., Ahmed, L., Vella, A., Chuang, L.-M., Bessler, M., Sarr, M. G., Swain, J. M., Laqua, P., Jensen, M. D., & Bantle, J. P.
- Affiliations
- University of Minnesota (US)
- National Taiwan University (TW)
- Mount Sinai Hospital (US)
- Min Sheng General Hospital (TW)
- Mayo Clinic (US)
- ORCID
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2013-06-05
- Volume
- 309
- Issue
- 21
- Pages
- 2240
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- PMC
- PMC3954742
- OpenAlex
- W2103955681
- Cited by
- 735
- References
- 32
- Citations by year
- 2026: 15 · 2025: 20 · 2024: 30 · 2023: 25 · 2022: 28 · 2021: 44 · 2020: 61 · 2019: 41 · 2018: 64 · 2017: 65 · 2016: 92 · 2015: 125 · 2014: 99 · 2013: 25
- FWCI
- 112.02
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- JAMA (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institutes of Health (UL1TR000040)
- National Institute of Diabetes and Digestive and Kidney Diseases (R01DK082396)
- National Center for Research Resources (UL1RR024156)
- National Center for Advancing Translational Sciences
- Topics
- Health Sciences › Medicine › Surgery › Bariatric Surgery and Outcomes
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Keywords
- Roux-en-Y gastric bypass, type 2 diabetes, lifestyle intervention, glycemic control, blood pressure control, hyperlipidemia, obesity, weight loss, bariatric surgery, medication reduction, HbA1c, LDL cholesterol, systolic blood pressure, comorbid risk factors
- MeSH terms
- Adult, Aged, Antihypertensive Agents, Hypolipidemic Agents, Blood Glucose, Diabetes Mellitus, Type 2, Female, Hospitals, Teaching, Humans, Hyperlipidemias, Hypertension, Hypoglycemic Agents, Life Style, Male, Middle Aged, Obesity, Risk Factors, Gastric Bypass, Weight Loss, 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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