NCT02193295 Reversal of Lipid-Induced Insulin Resistance
| NCT ID | NCT02193295 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yale University |
| Condition | Insulin Resistance |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2002-10 |
| Primary Completion | 2034-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2002-10 with a primary completion date of 2034-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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).
Eligibility 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.
Contact & Investigator
Kitt Petersen, MD
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT02193295 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Insulin Resistance. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02193295 currently recruiting?
Yes, NCT02193295 is actively recruiting participants. Contact the research team at kitt.petersen@yale.edu for enrollment information.
Where is the NCT02193295 trial being conducted?
This trial is being conducted at New Haven, United States, New Haven, United States.
Who is sponsoring the NCT02193295 clinical trial?
NCT02193295 is sponsored by Yale University. The principal investigator is Kitt Petersen, MD at Yale University. The trial plans to enroll 250 participants.