Weight Loss-Independent Metabolic Effects of Roux-En-Y Gastric Bypass in Diabetes
NCT ID: NCT02207777
Last Updated: 2025-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
65 participants
INTERVENTIONAL
2014-08-31
2019-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Roux-en-Y gastric bypass (RYGB)
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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
25 Years
65 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Samuel Klein, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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References
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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.
Samovski 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.
Smith 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.
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.
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.
Other Identifiers
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201403065
Identifier Type: -
Identifier Source: org_study_id
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