NCT02193295Recruiting
Reversal of Lipid-Induced Insulin Resistance
Source: ClinicalTrials.gov · Last updated 22 Jun 2026
Brief summary (registry, in English)
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. Hepatic mitochondrial oxidation will be assesses using a 3 hour triple tracer study (D7 glucose, 3-13C lactate and 13C4 beta-hydroxybutyrate).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- First submitted
- 25 Jun 2014
- Start date
- Oct 2002
- Primary completion date
- Oct 2034
- Lead sponsor
- Yale University
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT02193295
What you commit to
- Study type: Interventional
- Planned participants: 250
- From Oct 2002 to the primary completion date, Oct 2034
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Metal implants and/or body piercing, which cannot be removed before the MR studies.
Lab values
- 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)
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 90 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yale Center for Clinical Investigation HRU Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| Magnetic Resonance Research Center (MRRC) Coordinator of this site? Confirm its status | New Haven | United States | Enrolling by invitation |
This page is information, not medical advice. Discuss any trial with your doctor.