Weight Loss-Independent Metabolic Effects of Roux-En-Y Gastric Bypass in Diabetes (RBD-T2D)
Primary Purpose
Obesity, Type 2 Diabetes
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Roux-en-Y gastric bypass surgery
Low-calorie diet
Sponsored by
About this trial
This is an interventional basic science trial for Obesity focused on measuring Obesity, Roux-en-Y gastric bypass (RYGB), Type 2 Diabetes, Weight Loss, Low-Calorie Diet
Eligibility Criteria
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
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Roux-en-Y gastric bypass (RYGB)
Low-calorie diet
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Changes in hepatic insulin sensitivity
The outcome will be assessed by hyperinsulinemic-euglycemic-pancreatic-clamp procedure before and after weight loss.
Secondary Outcome Measures
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.
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.
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
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
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
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
Changes in body fat mass
The outcome will be measured by using dual-energy X-ray absorptiometry before and after weight loss
Changes in intra-abdominal adipose tissue volume
The outcome will be measured by using magnetic resonance imaging before and after weight loss
Changes in intrahepatic triglyceride content
The outcome will be measured by using magnetic resonance imaging before and after weight loss
Changes in fat free mass
The outcome will be measured by using dual-energy X-ray absorptiometry before and after weight loss
Full Information
NCT ID
NCT02207777
First Posted
July 31, 2014
Last Updated
April 21, 2023
Sponsor
Washington University School of Medicine
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT02207777
Brief Title
Weight Loss-Independent Metabolic Effects of Roux-En-Y Gastric Bypass in Diabetes
Acronym
RBD-T2D
Official Title
Weight Loss-Independent Metabolic Effects of Roux-En-Y Gastric Bypass in Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2014 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Type 2 Diabetes
Keywords
Obesity, Roux-en-Y gastric bypass (RYGB), Type 2 Diabetes, Weight Loss, Low-Calorie Diet
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Roux-en-Y gastric bypass (RYGB)
Arm Type
Experimental
Arm Description
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.
Arm Title
Low-calorie diet
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Roux-en-Y gastric bypass surgery
Intervention Description
A surgical procedure to help subjects lose approximately 16-18% (with a range of 16-25%) of their body weight.
Intervention Type
Behavioral
Intervention Name(s)
Low-calorie diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in hepatic insulin sensitivity
Description
The outcome will be assessed by hyperinsulinemic-euglycemic-pancreatic-clamp procedure before and after weight loss.
Time Frame
6 months (before and after targeted weight loss)
Secondary Outcome Measure Information:
Title
Changes in skeletal muscle and adipose tissue insulin sensitivity
Description
The outcome will be assessed by hyperinsulinemic-euglycemic-pancreatic-clamp procedure before and after weight loss.
Time Frame
6 months (before and after targeted weight loss)
Title
Changes in Beta-cell function
Description
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.
Time Frame
6 months (before and after targeted weight loss)
Title
Changes in glucose kinetics (glucose concentration and rate of appearance into the systemic circulation) in response to mixed-meal ingestion
Description
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
Time Frame
6 months (before and after targeted weight loss)
Title
Changes in 24-hour plasma glucose profile
Description
The outcome will be determined by obtaining serial plasma glucose concentration measurements for 24 hours before and after weight loss
Time Frame
6 months (before and after targeted weight loss)
Title
Changes in 24-hour plasma insulin profile
Description
The outcome will determined by obtaining serial plasma insulin concentration measurements for 24 hours before and after weight loss
Time Frame
6 months (before and after targeted weight loss)
Title
Changes in 24-hour plasma free fatty acid profile
Description
The outcome will determined by obtaining serial plasma free fatty acid concentration measurements for 24 hours before and after weight loss
Time Frame
6 months (before and after targeted weight loss)
Title
Changes in body fat mass
Description
The outcome will be measured by using dual-energy X-ray absorptiometry before and after weight loss
Time Frame
6 months (before and after targeted weight loss)
Title
Changes in intra-abdominal adipose tissue volume
Description
The outcome will be measured by using magnetic resonance imaging before and after weight loss
Time Frame
6 months (before and after targeted weight loss)
Title
Changes in intrahepatic triglyceride content
Description
The outcome will be measured by using magnetic resonance imaging before and after weight loss
Time Frame
6 months (before and after targeted weight loss)
Title
Changes in fat free mass
Description
The outcome will be measured by using dual-energy X-ray absorptiometry before and after weight loss
Time Frame
6 months (before and after targeted weight loss)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel Klein, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32813948
Citation
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. doi: 10.1056/NEJMoa2003697.
Results Reference
result
PubMed Identifier
32651241
Citation
van Vliet S, Koh HE, Patterson BW, Yoshino M, LaForest R, Gropler RJ, Klein S, Mittendorfer B. Obesity Is Associated With Increased Basal and Postprandial beta-Cell Insulin Secretion Even in the Absence of Insulin Resistance. Diabetes. 2020 Oct;69(10):2112-2119. doi: 10.2337/db20-0377. Epub 2020 Jul 10.
Results Reference
derived
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Weight Loss-Independent Metabolic Effects of Roux-En-Y Gastric Bypass in Diabetes
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