The Effects of a Moderate Weight Loss on Insulin Resistance
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 35
Summary
- Conditions
- Insulin Resistance
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Single Group AssignmentIntervention Model Description: On Jan 29, 2019 the study was approved by the Yale IRB to add the option of a cross-over study for participants, who are interested and willing to do so. On June 9, 2020 the study was approved to allow participants to complete only one arm of the double blind cross-over design study and to add Arm 3, which is a 48-week open label extension study to examine whether lowering of liver lipid content will be sustained safely over the longer-term treatment with GS-0976.Masking: Double (Participant, Investigator)Masking Description: This is a double-blind, placebo controlled study, which includes an open-label 48 week extension arm following either both arms or one arm of the double-blind crossover 12-week study.Primary Purpose: Basic Science
Participation Requirements
- Age
- Between 18 years and 90 years
- Gender
- Both males and females
Description
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 ...
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).
Tracking Information
- NCT #
- NCT02193295
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Gilead Sciences
- Investigators
- Principal Investigator: Kitt Petersen, MD Yale University
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