Abstract | BACKGROUND: METHODS: 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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Authors | Philip R Schauer, Sangeeta R Kashyap, Kathy Wolski, Stacy A Brethauer, John P Kirwan, Claire E Pothier, Susan Thomas, Beth Abood, Steven E Nissen, Deepak L Bhatt |
Journal | The New England journal of medicine
(N Engl J Med)
Vol. 366
Issue 17
Pg. 1567-76
(Apr 26 2012)
ISSN: 1533-4406 [Electronic] United States |
PMID | 22449319
(Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
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Chemical References |
- Glycated Hemoglobin A
- Hypoglycemic Agents
- Cholesterol
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Topics |
- Adult
- Body Mass Index
- Cholesterol
(blood)
- Combined Modality Therapy
- Diabetes Mellitus, Type 2
(complications, drug therapy, surgery)
- Female
- Follow-Up Studies
- Gastrectomy
- Gastric Bypass
- Glycated Hemoglobin
(analysis)
- Humans
- Hypoglycemic Agents
(therapeutic use)
- Male
- Metabolic Syndrome
(therapy)
- Middle Aged
- Obesity
(complications, surgery)
- Postoperative Complications
- Weight Loss
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