Reversal of Lipid-Induced Insulin Resistance
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorYale University
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Any subject, who does not fit the inclusion criteria. Including history of eating disorders, any systemic and organ disease including diabetes.
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Caloric Restriction
BehavioralDietary intervention to reduce lipid content in liver and muscle with minimal overall weight loss. Weekly visits for measurements of body weight, body composition, blood glucose and MRS measurements of liver and muscle lipid.
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: Lifestyle InterventionExperimental treatment 1 intervention
Group B: Baseline Assessment of Hepatic Mitochondrial Fat OxidationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Improvements in insulin sensitivity
Insulin sensitivity will be assessed using the insulin/glucose clamp, liver and muscle fat will be measured using 1H magnetic resonance spectroscopy (MRS) and both results from the clamp and MRS compared to baseline values before the weight reduction intervention.
Time frame
up to 6 months intervention to examine whether insulin sensitivity has improved significantly after the moderate weight reductionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov