Status:
RECRUITING
Reversal of Lipid-Induced Insulin Resistance
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Insulin Resistance
NAFLD
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
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 ar...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2034
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT02193295
Start Date
October 1 2002
End Date
December 1 2034
Last Update
May 16 2025
Active Locations (2)
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1
Magnetic Resonance Research Center (MRRC)
New Haven, Connecticut, United States, 06511
2
Yale Center for Clinical Investigation HRU
New Haven, Connecticut, United States, 06520