Randomized Comparative Effectiveness Pilot Trial of Laparoscopic Bariatric Surgery vs. Intensive Medical Weight Management on Diabetes Remission in Patients with Type 2 Diabetes who do NOT Meet NIH Criteria for Surgery and the Role of sRAGE Diabetes Biomarker as a Predictor of Success
Manish Parikh*1, Mimi Chung*1, Sheetal Sheth*1, Michelle McMacken*1, Tasneem Zahra*2, John K Saunders*1, Aku Ude-Welcome*1, Vann Dunn*3, Ggbenga Ogedegbe*1, Ann-Marie Schmidt*1, H L Pachter1
1NYU Medical Center/Bellevue Hospital, New York, NY;2Lincoln Health Center, New York, NY;3MetroPlus Health Plan, New York, NY
To compare bariatric surgery vs. intensive medical weight management (MWM) in patients with type 2 diabetes (T2DM) who do not meet current NIH criteria for surgery. To assess whether the soluble form of RAGE (receptor for advanced glycation endproducts) is an adequate diabetes biomarker that may help predict who would benefit most from surgery.
57 patients with T2DM and BMI 30-35 who otherwise met criteria for bariatric surgery were randomized to surgery (bypass, sleeve or band, based on patient preference) vs. MWM. HOMA-IR, HbA1c, weight, BMI, blood pressure, waist circumference, fasting lipids and sRAGE levels
were collected at baseline and at 6 months. The primary outcomes assessed were (1) change in insulin resistance and (2) remission of diabetes. Secondary outcomes included changes in weight,
HbA1c , and sRAGE.
The surgery group had significantly higher diabetes remission (61% vs.
0%; p<0.0001) and significantly lower HOMA-IR (1.8 vs. 4.7; p=0.013) than the MWM group. The surgery group had significantly lower post-prandial glucose (130 vs. 306; p<0.0001) and fewer diabetes medication requirements (20% vs. 80%;p<0.0001). The surgery group had
significantly better weight loss (-7.0 vs. -1.0 BMI decrease; p>0.0001),
lower waist circumference (91.4cm vs. 105cm; p<0.0001) and lower HBA1c (6.2 vs. 7.8; p=0.0002). Higher baseline sRAGE was significantly associated with better weight loss outcomes (r=-0.641; p=0.046). There were no mortalities.
Surgery was very effective short-term in patients with T2DM and BMI
30-35. Baseline sRAGE may predict success. These findings need to be confirmed with larger studies.
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