Bariatric surgery versus intensive medical therapy in obese patients with diabetes.

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.).

[1]  P. Zimmet,et al.  Surgery or medical therapy for obese patients with type 2 diabetes? , 2012, The New England journal of medicine.

[2]  R. Abramof.  Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes , 2012 .

[3]  P. Schauer,et al.  A focus on surgical preoperative evaluation of the bariatric patient--the Cleveland Clinic protocol and review of the literature. , 2011, The surgeon : journal of the Royal Colleges of Surgeons of Edinburgh and Ireland.

[4]  M. Ezzati,et al.  National, regional, and global trends in fasting plasma glucose and diabetes prevalence since 1980: systematic analysis of health examination surveys and epidemiological studies with 370 country-years and 2·7 million participants , 2011, The Lancet.

[5]  L. Chuang,et al.  Gastric bypass vs sleeve gastrectomy for type 2 diabetes mellitus: a randomized controlled trial. , 2011, Archives of surgery.

[6]  Arya M. Sharma,et al.  Sleeve gastrectomy and type 2 diabetes mellitus: a systematic review. , 2010, Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery.

[7]  Deepak L. Bhatt,et al.  Bariatric surgery vs. advanced practice medical management in the treatment of type 2 diabetes mellitus: rationale and design of the Surgical Therapy And Medications Potentially Eradicate Diabetes Efficiently trial (STAMPEDE) , 2010, Diabetes, obesity & metabolism.

[8]  P. Schauer,et al.  Acute effects of gastric bypass versus gastric restrictive surgery on β-cell function and insulinotropic hormones in severely obese patients with type 2 diabetes , 2010, International Journal of Obesity.

[9]  B. Wolfe,et al.  Perioperative safety in the longitudinal assessment of bariatric surgery. , 2009, The New England journal of medicine.

[10]  V. Woo.  Medical Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy: A Consensus Statement of the American Diabetes Association and the European Association for the Study of Diabetes , 2009, Diabetes Care.

[11]  M. Jensen,et al.  Weight and type 2 diabetes after bariatric surgery: systematic review and meta-analysis. , 2009, The American journal of medicine.

[12]  D. Nathan.  Medical Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy: A Consensus Statement of the American Diabetes Association and the European Association for the Study of Diabetes , 2009, Diabetes Care.

[13]  Margaret Anderson,et al.  Adjustable gastric banding and conventional therapy for type 2 diabetes: a randomized controlled trial. , 2008, JAMA.

[14]  J. Holst,et al.  Exaggerated glucagon-like peptide-1 and blunted glucose-dependent insulinotropic peptide secretion are associated with Roux-en-Y gastric bypass but not adjustable gastric banding. , 2007, Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery.

[15]  Steven C Hunt,et al.  Long-term mortality after gastric bypass surgery. , 2007, The New England journal of medicine.

[16]  G. Bray,et al.  Reduction in Weight and Cardiovascular Disease Risk Factors in Individuals With Type 2 Diabetes , 2007, Diabetes Care.

[17]  N. Scopinaro,et al.  Specific effects of biliopancreatic diversion on the major components of metabolic syndrome: a long-term follow-up study. , 2005, Diabetes care.

[18]  D. Cummings,et al.  Hormonal mechanisms of weight loss and diabetes resolution after bariatric surgery. , 2005, Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery.

[19]  Claude Bouchard,et al.  Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. , 2004, The New England journal of medicine.

[20]  S. Saydah,et al.  Poor control of risk factors for vascular disease among adults with previously diagnosed diabetes. , 2004, JAMA.

[21]  Aesha Drozdowski,et al.  Standards of medical care in diabetes. , 2004, Diabetes care.

[22]  L. Kuller,et al.  Effect of Laparoscopic Roux-En Y Gastric Bypass on Type 2 Diabetes Mellitus , 2003, Annals of surgery.

[23]  P. Schauer,et al.  Laparoscopic gastric bypass surgery: current technique. , 2003, Journal of laparoendoscopic & advanced surgical techniques. Part A.

[24]  W. Pories,et al.  Who Would Have Thought It? An Operation Proves to Be the Most Effective Therapy for Adult‐Onset Diabetes Mellitus , 1995, Annals of surgery.

[25]  V. Basevi.  Standards of Medical Care in Diabetes—2011 , 2011, Diabetes Care.