RECRUITING

Reversal of Lipid-Induced Insulin Resistance

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Conditions

Insulin ResistanceNAFLDWeight ReductionCaloric RestrictionEuglycemic Hyperinsulinemic ClampMagnetic Resonance SpectroscopyPINTA

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Reversal of Lipid-Induced Insulin Resistance

Quick Facts

Study Start:2002-10
Study Completion:2034-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02193295

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Healthy, sedentary, non-smoking and not taking any medications other than birth control pills.
  2. * Hematocrit \>35%
  3. * Subjects will have no systemic or organ disease including diabetes.
  4. * Subjects will have no history eating disorders.
  5. * 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.
  6. * Those who are taking birth control pills or have had a hysterectomy may be studied at any time.
  7. * Physical activity will be assessed using a standard questionnaire with an activity index cut off at 2.3.
  1. * Any subject, who does not fit the inclusion criteria. Including history of eating disorders, any systemic and organ disease including diabetes.
  2. * Hematocrit \<35%.
  3. * Women of childbearing potential, who are not using contraception (as mentioned above) or who are not abstinent.
  4. * Subjects who have a regular exercise regimen will not be enrolled.
  5. * Metal implants and/or body piercing, which cannot be removed before the MR studies.

Contacts and Locations

Study Contact

Kitt Petersen, MD
CONTACT
203-785-5447
kitt.petersen@yale.edu

Principal Investigator

Kitt Petersen, MD
PRINCIPAL_INVESTIGATOR
Yale University

Study Locations (Sites)

Magnetic Resonance Research Center (MRRC)
New Haven, Connecticut, 06511
United States
Yale Center for Clinical Investigation HRU
New Haven, Connecticut, 06520
United States

Collaborators and Investigators

Sponsor: Yale University

  • Kitt Petersen, MD, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2002-10
Study Completion Date2034-12

Study Record Updates

Study Start Date2002-10
Study Completion Date2034-12

Terms related to this study

Keywords Provided by Researchers

  • Weight Reduction
  • Caloric Restriction
  • Euglycemic Hyperinsulinemic Clamp
  • Magnetic Resonance Spectroscopy
  • PINTA

Additional Relevant MeSH Terms

  • Insulin Resistance
  • NAFLD