Reversal of Lipid-Induced Insulin Resistance
Recruiting · NCT02193295 · Interventional (participants receive a specific treatment) · Lead sponsor: Yale University
View the official record on ClinicalTrials.gov →Interventions studied
Caloric Restriction
What this trial is about
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).
Who can take part
Age range
18 Years to 90 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
2 locations listed across 1 US state.
- Magnetic Resonance Research Center (MRRC) - New Haven, Connecticut, United States
- Yale Center for Clinical Investigation HRU - New Haven, Connecticut, United States