Weight Loss-Independent Metabolic Effects of Roux-En-Y Gastric Bypass in Diabetes

Obesity Clinical Trial

— RBD-T2D  

Official title:

Weight Loss-Independent Metabolic Effects of Roux-En-Y Gastric Bypass in Diabetes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02207777
• Other study ID #: 201403065
• Secondary ID: 1R01DK101578
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2014
• Est. completion date: April 2026

Study information

• Verified date: April 2024
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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-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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: April 2026
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes
• Weight Loss

Intervention

Procedure:
• Roux-en-Y gastric bypass surgery
A surgical procedure to help subjects lose approximately 16-18% (with a range of 16-25%) of their body weight.

Behavioral:
• Low-calorie diet
Subjects will meet with a dietitian and/or behaviorist over approximately 6 months to lose approximately 16-18% (with a range of 16-25%) of their body weight.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Yoshino M, Kayser BD, Yoshino J, Stein RI, Reeds D, Eagon JC, Eckhouse SR, Watrous JD, Jain M, Knight R, Schechtman K, Patterson BW, Klein S. Effects of Diet versus Gastric Bypass on Metabolic Function in Diabetes. N Engl J Med. 2020 Aug 20;383(8):721-732 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in hepatic insulin sensitivity	The outcome will be assessed by hyperinsulinemic-euglycemic-pancreatic-clamp procedure before and after weight loss.	6 months (before and after targeted weight loss)
Secondary	Changes in skeletal muscle and adipose tissue insulin sensitivity	The outcome will be assessed by hyperinsulinemic-euglycemic-pancreatic-clamp procedure before and after weight loss.	6 months (before and after targeted weight loss)
Secondary	Changes in Beta-cell function	The outcome will be assessed as the product of beta-cell glucose sensitivity (ratio of post-meal insulin secretion rate to post-meal plasma glucose) during mixed-meal test and whole-body insulin sensitivity before and after weight loss.	6 months (before and after targeted weight loss)
Secondary	Changes in glucose kinetics (glucose concentration and rate of appearance into the systemic circulation) in response to mixed-meal ingestion	The outcome will be measured by using dual glucose tracer mixed meal metabolic test and serial blood sampling for 4 hours before and after weight loss	6 months (before and after targeted weight loss)
Secondary	Changes in 24-hour plasma glucose profile	The outcome will be determined by obtaining serial plasma glucose concentration measurements for 24 hours before and after weight loss	6 months (before and after targeted weight loss)
Secondary	Changes in 24-hour plasma insulin profile	The outcome will determined by obtaining serial plasma insulin concentration measurements for 24 hours before and after weight loss	6 months (before and after targeted weight loss)
Secondary	Changes in 24-hour plasma free fatty acid profile	The outcome will determined by obtaining serial plasma free fatty acid concentration measurements for 24 hours before and after weight loss	6 months (before and after targeted weight loss)
Secondary	Changes in body fat mass	The outcome will be measured by using dual-energy X-ray absorptiometry before and after weight loss	6 months (before and after targeted weight loss)
Secondary	Changes in intra-abdominal adipose tissue volume	The outcome will be measured by using magnetic resonance imaging before and after weight loss	6 months (before and after targeted weight loss)
Secondary	Changes in intrahepatic triglyceride content	The outcome will be measured by using magnetic resonance imaging before and after weight loss	6 months (before and after targeted weight loss)
Secondary	Changes in fat free mass	The outcome will be measured by using dual-energy X-ray absorptiometry before and after weight loss	6 months (before and after targeted weight loss)