Weight loss to improve insulin sensitivity in insulin-resistant individuals
Reversal of Lipid-Induced Insulin Resistance
This study is testing if losing a little weight can help lean people who are insulin-resistant and have a family history of type 2 diabetes improve how their bodies handle sugar and fat.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 2 sites (New Haven, Connecticut and 1 other locations) |
| Trial ID | NCT02193295 on ClinicalTrials.gov |
What this trial studies
This study investigates whether a small weight loss can reduce lipid content in muscle and liver, thereby improving insulin sensitivity in lean, insulin-resistant individuals with a family history of type 2 diabetes. Participants will undergo a series of metabolic assessments, including glucose metabolism and lipolysis measurements, before and after a caloric restriction intervention. The study aims to compare these effects with a control group of individuals without a family history of diabetes, using advanced techniques such as euglycemic hyperinsulinemic clamps and magnetic resonance spectroscopy.
Who should consider this trial
Good fit: Ideal candidates are healthy, sedentary individuals with insulin resistance and a family history of type 2 diabetes.
Not a fit: Patients with systemic diseases, diabetes, or a history of eating disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to effective weight management strategies that improve insulin sensitivity and reduce the risk of type 2 diabetes in at-risk populations.
How similar studies have performed: Other studies have shown promising results in improving insulin sensitivity through weight loss in similar populations, indicating that this approach is supported by existing research.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New Haven, Connecticut and 1 other locations
- Magnetic Resonance Research Center (MRRC) — New Haven, Connecticut, United States (Enrolling_by_invitation)
- Yale Center for Clinical Investigation HRU — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Kitt Petersen, MD — Yale University
- Study coordinator: Kitt Petersen, MD
- Email: kitt.petersen@yale.edu
- Phone: 203-785-5447
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.