Randomized pilot trial of bariatric surgery versus intensive medical weight management on diabetes remission in type 2 diabetic patients who do not meet NIH criteria for surgery and the role of soluble RAGE as a novel biomarker of success

Objective: To compare bariatric surgery versus intensive medicalweight management (MWM) in patients with type 2 diabetes mellitus (T2DM) who do not meet current National Institutes of Health criteria for bariatric surgery and to assess whether the soluble form of receptor for advanced glycation end products (sRAGE) is a biomarker to identify patients most likely to benefit from surgery.

Background: There are few studies comparing surgery toMWMfor patients with T2DM and BMI less than 35. Methods: Fiftyseven patients with T2DM and BMI 30 to 35, who otherwise met the criteria for bariatric surgery were randomized toMWMversus surgery (bypass, sleeve or band, based on patient preference). The primary outcomes assessed at 6 months were change in homeostatic model of insulin resistance (HOMAIR) and diabetes remission. Secondary outcomes included changes in HbA1c, weight, and sRAGE.

Results: The surgery group had improved HOMAIR ( 4.6 vs +1.6; P = 0.0004) and higher diabetes remission (65% vs 0%, P 0.0001) than the MWM group at 6 months. Compared to MWM, the surgery group had lower HbA1c (6.2 vs 7.8, P = 0.002), lower fasting glucose (99.5 vs 157; P = 0.0068), and fewer T2DMmedication requirements (20% vs 88%; P0.0001) at 6 months. The surgery group lost more weight (7. vs 1.0 BMI decrease, P 0.0001). Higher baseline sRAGE was associated with better weight loss outcomes (r= 0.641; P = 0.046). There were no mortalities.

Conclusions: Surgery was very effective shortterm in patients with T2DM and BMI 30 to 35. Baseline sRAGE may predict patients most likely to benefit from surgery. These findings need to be confirmed with larger studies. ClinicalTrials.gov ID: NCT01423877.