Structured Abstract
Objective
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 bariatric surgery.
To assess whether the soluble form of receptor for advanced glycation endproducts (sRAGE) is a biomarker to identify patients most likely to benefit from surgery.
Summary Background Data
There are few studies comparing surgery to MWM for patients with T2DM and BMI < 35.
Methods
57 patients with T2DM and BMI 30–35 who otherwise met criteria for bariatric surgery were randomized to MWM vs. surgery (bypass, sleeve or band, based on patient preference). The primary outcomes assessed at 6 months were change in 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 (7.0 BMI decrease 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 30–35. Baseline sRAGE may predict patients most likely to benefit from surgery. These findings need to be confirmed with larger studies.
ClinicalTrials.gov ID: NCT01423877
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