Clinical trial NCT02207777: Weight Loss-Independent Metabolic Effects of Roux-En-Y Gastric Bypass in Diabetes
Official title: Weight Loss-Independent Metabolic Effects of Roux-En-Y Gastric Bypass in Diabetes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity
Type 2 Diabetes
Keywords: Obesity
Roux-en-Y gastric bypass (RYGB)
Type 2 Diabetes
Weight Loss
Low-Calorie Diet
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2014-08-04
Enrollment: 70
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Changes in hepatic insulin sensitivity
timeFrame: 6 months (before and after targeted weight loss)
Secondary outcomes:
measure: Changes in skeletal muscle and adipose tissue insulin sensitivity
timeFrame: 6 months (before and after targeted weight loss)
measure: Changes in Beta-cell function
timeFrame: 6 months (before and after targeted weight loss)
measure: Changes in glucose kinetics (glucose concentration and rate of appearance into the systemic circulation) in response to mixed-meal ingestion
timeFrame: 6 months (before and after targeted weight loss)
measure: Changes in 24-hour plasma glucose profile
timeFrame: 6 months (before and after targeted weight loss)
measure: Changes in 24-hour plasma insulin profile
timeFrame: 6 months (before and after targeted weight loss)
measure: Changes in 24-hour plasma free fatty acid profile
timeFrame: 6 months (before and after targeted weight loss)
measure: Changes in body fat mass
timeFrame: 6 months (before and after targeted weight loss)
measure: Changes in intra-abdominal adipose tissue volume
timeFrame: 6 months (before and after targeted weight loss)
measure: Changes in intrahepatic triglyceride content
timeFrame: 6 months (before and after targeted weight loss)
measure: Changes in fat free mass
timeFrame: 6 months (before and after targeted weight loss)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Samuel Klein, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.