Status:
COMPLETED
Weight Loss-Independent Metabolic Effects of Roux-En-Y Gastric Bypass in Diabetes
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Obesity
Type 2 Diabetes
Eligibility:
All Genders
25-65 years
Phase:
NA
Brief Summary
For this purpose, we will compare the effects of targeted 16-18% (with a range of 16-25%) weight loss induced by Roux-en-Y Gastric bypass (RYGB) surgery with the same weight loss induced by a low-calo...
Eligibility Criteria
Inclusion
- For RYGB group:
- Scheduled for this bariatric surgery
- Body Mass Index (BMI) 34-55 kg/m²
- Type 2 Diabetes
- Signed informed consent
- For Low-Calorie Diet group:
- BMI 34-55 kg/m²
- Type 2 Diabetes and Non-Diabetics
- Signed informed consent
Exclusion
- For both RYGB \& Low-Calorie Diet groups
- Regular use of tobacco products
- Previous intestinal resection
- Pregnant or breastfeeding
- Evidence of significant organ system dysfunction or disease other than T2D
- Use of any medication that might, in the opinion of the investigator, affect metabolic function
- Exercise ≥90 minutes per week
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT02207777
Start Date
August 1 2014
End Date
March 1 2019
Last Update
July 20 2025
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110