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CROSSROADS: Surgery betters ILMI on diabetes remission
Gastric bypass yielded greater type 2 diabetes remission in mild-moderately obese patients, compared to intensive lifestyle & medical intervention (ILMI), according to the results from the ‘Gastric Bypass Surgery vs. Highly Intensive Lifestyle and Medical Intervention to Manage Type 2 Diabetes: The CROSSROADS Randomized Clinical Trial’.
Presented by Dr David E Cummings from the University of Washington, Seattle, WA, this randomised controlled trial compared Roux-en-Y gastric bypass (RYGB) to the most rigorous lifestyle-medical intervention for type 2 diabetes yet studied in such an RCT.
Using a population based, shared decision making recruitment strategy, the researchers screened 1,808 adults with T2DM and BMI 30-45. Of these, 43 were randomised to RYGB or a highly intensive lifestyle & medical intervention (ILMI).
The lifestyle intervention included behaviour-modification skills counselling combined with training in diet and exercise change. The focus of the exercise intervention is a gradual increase in brisk walking or other activities of similar moderate aerobic intensity. The exercise prescription will consist of at least 45 minutes of exercise, five days per week for 12 months.
Patients randomised to the surgical arm will undergo a standard laparoscopic proximal RYGB, as commonly practiced by GH surgeons, using a 90cm alimentary limb, 50cm biliopancreatic limb, antecolic/antegastric approach, and totally stapled technique.
All patients attended follow-up research visits at three, six, nine, and 12 months after randomisation, where they underwent a standardized physically exam, as well as weight, waist and hip circumferences; systolic and diastolic blood pressure; resting 1-minute pulse; and fasting (12-hour) blood (50 ml) collection.
The groups were equivalent at baseline for age, gender, ethnicity, anthropometrics, fitness, glycaemia, dyslipidemia, and hypertension. However, the surgical group had longer T2DM duration (11.4±4.8 vs. 6.8±5.2 year, p=0.009).
Weight loss at one year was 25.8±14.5 vs. 6.4±5.8% after RYGB vs. ILMI, respectively (p<0.001). The researchers reported that ILMI exercise programme was successful, yielding a 30.1±16.9% increase in VO2max, but an even greater 46.3±16.7% increase was reported in the surgical group (p=0.005).
Diabetes remission (HbA1c<6.0% off diabetes medicines) at one year was 60% with RYGB vs. 6% with ILMI (p=0.002), even though surgical patients had longer T2DM duration.
HbA1c decline over one year was only modestly more after RYGB than ILMI (from 7.7±1.0 to 6.4±1.6% vs. 7.3±0.9 to 6.9±1.3%, respectively, p=0.04). However, this drop occurred with fewer medications after RYGB.
The researchers reported that there were no life-threatening complications.
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