The Effects of a Moderate Weight Loss on Insulin Resistance
The purpose of this study is to examine whether weight reduction decreases intramyocellular (IMCL) and hepatic lipid content, and improves insulin sensitivity of muscle and fat tissue in people who are insulin resistant and have a family history of type 2 diabetes.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||The Effects of a Moderate Weight Loss on Muscle and Liver Fat Content and Reversal of Insulin Resistance|
- Improvements in insulin sensitivity [ Time Frame: up to 6 months intervention to examine whether insulin sensitivity has improved significantly after the moderate weight reduction ] [ Designated as safety issue: No ]Insulin sensitivity will be assessed using the insulin/glucose clamp, liver and muscle fat will be measured using 1H magnetic resonance spectroscopy (MRS) and both results from the clamp and MRS compared to baseline values before the weight reduction intervention.
|Study Start Date:||October 2002|
|Estimated Study Completion Date:||October 2022|
|Estimated Primary Completion Date:||October 2021 (Final data collection date for primary outcome measure)|
Experimental: Lifestyle Intervention
Caloric Restriction. One arm.
Behavioral: Dietary consultations
Dietary consultations and caloric restriction to reduce liver and intra myocellular fat content and improve tissue specific insulin sensitivity
In this study, we will examine whether a small weight loss in lean, insulin-resistant offspring of type 2 diabetic patients will improve insulin resistance. The control group will consist of subjects matched for gender, age and body weight with no family history of diabetes. Before and after weight loss, rates of basal and insulin stimulated whole body glucose metabolism will be measured using [6,6-2H] glucose during a 3 hour basal period and a 4 hour euglycemic hyperinsulinemic (20 mU/m2-min) clamp. Rates of whole body lipolysis will be determined using [2H5] glycerol, localized rates of lipolysis will be measured using the microdialysis technique and muscle PI 3-kinase activity will be assessed in muscle biopsies. FFA metabolites (fatty acyl CoA, ceramides, diacylglycerol) will be measured in fat tissue collected from the abdominal subcutaneous fat cell depot. Body composition will be determined with bioelectrical impedance and whole body MRI; IMCL will be measured with MRS. Before and after weight loss, insulin secretion will be measured with the hyperglycemic clamp (as described under Day 2 Hyperglycemic Clamp).
Please refer to this study by its ClinicalTrials.gov identifier: NCT02193295
|Contact: Kitt Petersen, MDemail@example.com|
|United States, Connecticut|
|Yale Center for Clinical Investigation HRU||Recruiting|
|New Haven, Connecticut, United States, 06520|
|Contact: Kitt Petersen, MD 203-688-4106|
|Principal Investigator: Kitt Petersen, MD|
|Principal Investigator:||Kitt Petersen, MD||Yale University|