Weight Loss-Independent Metabolic Effects of Roux-En-Y Gastric Bypass in Diabetes
RBD-T2D
2 other identifiers
interventional
65
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Aug 2014
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedFirst Posted
Study publicly available on registry
August 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedJuly 20, 2025
July 1, 2025
4.6 years
July 31, 2014
July 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
Changes in skeletal muscle and adipose tissue insulin sensitivity
6 months (before and after targeted weight loss)
Changes in Beta-cell function
6 months (before and after targeted 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)
Changes in 24-hour plasma glucose profile
6 months (before and after targeted weight loss)
Changes in 24-hour plasma insulin profile
6 months (before and after targeted weight loss)
- +5 more secondary outcomes
Study Arms (2)
Roux-en-Y gastric bypass (RYGB)
EXPERIMENTALSubjects 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.
Low-calorie diet
ACTIVE COMPARATORSubjects in this group will participate in a low-calorie diet intervention to obtain approximately 16-18% (with a range of 16-25%) weight loss.
Interventions
A surgical procedure to help subjects lose approximately 16-18% (with a range of 16-25%) of their body weight.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Related Publications (5)
Petersen MC, Yoshino M, Smith GI, Gaspar RC, Kahn M, Samovski D, Shulman GI, Klein S. Effect of Weight Loss on Skeletal Muscle Bioactive Lipids in People With Obesity and Type 2 Diabetes. Diabetes. 2024 Dec 1;73(12):2055-2064. doi: 10.2337/db24-0083.
PMID: 39264820BACKGROUNDSamovski D, Smith GI, Palacios H, Pietka T, Fuchs A, Patti GJ, Nawaz A, Kahn CR, Klein S. Effect of Marked Weight Loss on Adipose Tissue Biology in People With Obesity and Type 2 Diabetes. Diabetes Care. 2025 Aug 1;48(8):1342-1351. doi: 10.2337/dc24-2739.
PMID: 40208704BACKGROUNDSmith GI, Klein S. Plasma endotrophin levels correlate with insulin resistance in people with obesity. J Clin Invest. 2025 Apr 22;135(12):e190577. doi: 10.1172/JCI190577. eCollection 2025 Jun 16. No abstract available.
PMID: 40261704BACKGROUNDYoshino 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.
PMID: 32813948BACKGROUNDvan 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.
PMID: 32651241DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Samuel Klein, MD
Washington University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2014
First Posted
August 4, 2014
Study Start
August 1, 2014
Primary Completion
March 1, 2019
Study Completion
March 1, 2019
Last Updated
July 20, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share