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

Not Applicable

Active, not recruiting

• Conditions: Type 2 Diabetes; Obesity
• Interventions: Behavioral: Low-calorie diet; Procedure: Roux-en-Y gastric bypass surgery

• Registration Number: NCT02207777
• Lead Sponsor: Washington University School of Medicine

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-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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-31
• Study First Submitted QC: 2014-07-31
• Study Start: 2014-08
• Study First Posted: 2014-08-04
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-24
• Primary Completion: 2025-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 70

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-calorie diet	Low-calorie diet	Subjects in this group will participate in a low-calorie diet intervention to obtain approximately 16-18% (with a range of 16-25%) weight loss.
Roux-en-Y gastric bypass (RYGB)	Roux-en-Y gastric bypass surgery	Subjects in this group are scheduled to undergo roux-en-Y gastric bypass surgery to obtain approximately 16-18% (with a range of 16-25%) weight loss.

Primary Outcome Measures

Name	Time	Method
Changes in hepatic insulin sensitivity	6 months (before and after targeted weight loss)	The outcome will be assessed by hyperinsulinemic-euglycemic-pancreatic-clamp procedure before and after weight loss.

Secondary Outcome Measures

Name	Time	Method
Changes in skeletal muscle and adipose tissue insulin sensitivity	6 months (before and after targeted weight loss)	The outcome will be assessed by hyperinsulinemic-euglycemic-pancreatic-clamp procedure before and after weight loss.
Changes in glucose kinetics (glucose concentration and rate of appearance into the systemic circulation) in response to mixed-meal ingestion	6 months (before and after targeted weight loss)	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
Changes in 24-hour plasma insulin profile	6 months (before and after targeted weight loss)	The outcome will determined by obtaining serial plasma insulin concentration measurements for 24 hours before and after weight loss
Changes in body fat mass	6 months (before and after targeted weight loss)	The outcome will be measured by using dual-energy X-ray absorptiometry before and after weight loss
Changes in 24-hour plasma glucose profile	6 months (before and after targeted weight loss)	The outcome will be determined by obtaining serial plasma glucose concentration measurements for 24 hours before and after weight loss
Changes in 24-hour plasma free fatty acid profile	6 months (before and after targeted weight loss)	The outcome will determined by obtaining serial plasma free fatty acid concentration measurements for 24 hours before and after weight loss
Changes in fat free mass	6 months (before and after targeted weight loss)	The outcome will be measured by using dual-energy X-ray absorptiometry before and after weight loss
Changes in Beta-cell function	6 months (before and after targeted weight loss)	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.
Changes in intrahepatic triglyceride content	6 months (before and after targeted weight loss)	The outcome will be measured by using magnetic resonance imaging before and after weight loss
Changes in intra-abdominal adipose tissue volume	6 months (before and after targeted weight loss)	The outcome will be measured by using magnetic resonance imaging before and after weight loss

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States