Overview

The Effects of a Moderate Weight Loss on Insulin Resistance

Status:
Recruiting
Trial end date:
2024-10-01
Target enrollment:
0
Participant gender:
All
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 are insulin resistant and have a family history of type 2 diabetes.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Yale University
Collaborators:
Gilead Sciences
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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.