New Haven, Connecticut 06520

  • Insulin Resistance

Purpose:

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 summary:

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).


Criteria:

Inclusion Criteria: - Healthy, sedentary, non-smoking and not taking any medications other than birth control pills. - Hematocrit >35% - Subjects will have no systemic or organ disease including diabetes. - Subjects will have no history eating disorders. - Women must be using a form of birth control (sexual abstinence, birth control pills, Norplant, IUD or condoms) and will be studied between day 0 and 7 of their menstrual cycle. - Those who are taking birth control pills or have had a hysterectomy may be studied at any time. - Physical activity will be assessed using a standard questionnaire with an activity index cut off at 2.3. Exclusion Criteria: - Any subject, who does not fit the inclusion criteria. Including history of eating disorders, any systemic and organ disease including diabetes. Lactose intolerance Any blood count, clotting abnormalities HYpertriglyceridemeia (TG over 100 mg/dL) - Hematocrit <35%. - Women of childbearing potential, who are not using contraception (as mentioned above) or who are not abstinent. - Subjects who have a regular exercise regimen will not be enrolled. - Metal implants and/or body piercing, which cannot be removed before the MR studies.


NCT ID:

NCT02193295


Primary Contact:

Principal Investigator
Kitt Petersen, MD
Yale University

Kitt Petersen, MD
Phone: 203-688-4106
Email: kitt.petersen@yale.edu


Backup Contact:

N/A


Location Contact:

New Haven, Connecticut 06520
United States

Kitt Petersen, MD
Phone: 203-688-4106

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 18, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.