Weight Loss-Independent Metabolic Effects of Roux-En-Y Gastric Bypass in Diabetes (RBD-T2D)

The Washington University

Status

Completed

Conditions

Obesity

Type 2 Diabetes

Treatments

Behavioral: Low-calorie diet

Procedure: Roux-en-Y gastric bypass surgery

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02207777

201403065

1R01DK101578 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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-calorie diet (LCD) on liver and skeletal muscle insulin sensitivity, beta-cell function, and 24-hour metabolic homeostasis in obese subjects with or without T2D.

Enrollment

65 patients

Sex

All

Ages

25 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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