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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
65
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.
Washington University School of Medicine
St Louis, Missouri, United States
Changes in hepatic insulin sensitivity
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)
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.
Time frame: 6 months (before and after targeted 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.
Time frame: 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
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)
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
Time frame: 6 months (before and after targeted 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
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Time frame: 6 months (before and after targeted 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
Time frame: 6 months (before and after targeted weight loss)
Changes in body fat mass
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)
Changes in intra-abdominal adipose tissue volume
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)
Changes in intrahepatic triglyceride content
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)
Changes in fat free mass
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)