title: 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.
abstract: OBJECTIVE
  To compare bariatric surgery versus intensive medical weight 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 to MWM for patients with T2DM and BMI less than 35.
  
  
  METHODS
  Fifty-seven patients with T2DM and BMI 30 to 35, who otherwise met the criteria for bariatric surgery were randomized to MWM versus surgery (bypass, sleeve or band, based on patient preference). The primary outcomes assessed at 6 months were change in homeostatic model of insulin resistance (HOMA-IR) and diabetes remission. Secondary outcomes included changes in HbA1c, weight, and sRAGE.
  
  
  RESULTS
  The surgery group had improved HOMA-IR (-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 T2DM medication requirements (20% vs 88%; P < 0.0001) 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 short-term 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.
authors.affiliation: Departments of *Surgery †Medicine ‡Population Health, NYU School of Medicine/Bellevue Hospital §Department of Medicine, Lincoln Hospital; and ¶MetroPlus Health Plan, Health and Hospitals Corporation, New York City, NY.
authors.forename: Manish
authors.initials: M
authors.lastname: Parikh
authors.forename: Mimi
authors.initials: M
authors.lastname: Chung
authors.forename: Sheetal
authors.initials: S
authors.lastname: Sheth
authors.forename: Michelle
authors.initials: M
authors.lastname: McMacken
authors.forename: Tasneem
authors.initials: T
authors.lastname: Zahra
authors.forename: John K
authors.initials: JK
authors.lastname: Saunders
authors.forename: Aku
authors.initials: A
authors.lastname: Ude-Welcome
authors.forename: Van
authors.initials: V
authors.lastname: Dunn
authors.forename: Gbenga
authors.initials: G
authors.lastname: Ogedegbe
authors.forename: Ann Marie
authors.initials: AM
authors.lastname: Schmidt
authors.forename: H Leon
authors.initials: HL
authors.lastname: Pachter
mesh_terms: D000328:Adult; D050110:Bariatric Surgery; D015415:Biomarkers / Q000032:analysis; D015992:Body Mass Index; D003376:Counseling; D003924:Diabetes Mellitus, Type 2 / Q000150:complications* / Q000628:therapy*; D005081:Exercise Therapy; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D017127:Glycation End Products, Advanced / Q000032:analysis*; D006801:Humans; D007333:Insulin Resistance; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000150:complications* / Q000601:surgery / Q000628:therapy*; D010865:Pilot Projects; D000067759:Receptor for Advanced Glycation End Products; D011971:Receptors, Immunologic / Q000032:analysis*; D012074:Remission Induction; D015431:Weight Loss
chemical_list: D015415:Biomarkers; D006442:Glycated Hemoglobin; D017127:Glycation End Products, Advanced; D000067759:Receptor for Advanced Glycation End Products; D011971:Receptors, Immunologic