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Search / Trial NCT02193295

Reversal of Lipid-Induced Insulin Resistance

Launched by YALE UNIVERSITY · Jul 16, 2014

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Weight Reduction Caloric Restriction Euglycemic Hyperinsulinemic Clamp Magnetic Resonance Spectroscopy Pinta

ClinConnect Summary

This clinical trial is exploring whether losing weight can help improve insulin sensitivity in individuals who are insulin resistant and have a family history of type 2 diabetes. Insulin resistance means the body doesn’t respond well to insulin, which can lead to high blood sugar levels and potentially diabetes. The study will measure how weight loss affects fat stored in muscles and the liver, which are important for insulin function.

To participate in this study, you should be a healthy adult aged 18 to 75, who does not smoke and is not taking any medications except for birth control. You should not have any diseases, especially diabetes, and should not have a history of eating disorders. Participants will engage in some assessments, including a three-hour test to check how their body processes different substances. It’s important to note that those who regularly exercise or have certain health conditions will not be eligible to participate. If you meet the criteria and are interested, this study could provide valuable insights into improving insulin sensitivity through weight loss.

Gender

ALL

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.

About Yale University

Yale University, a prestigious Ivy League institution located in New Haven, Connecticut, is renowned for its commitment to advancing medical research and clinical innovation. With a rich history of academic excellence and a robust infrastructure for scientific inquiry, Yale serves as a leading sponsor for clinical trials aimed at improving patient care and developing new therapeutic approaches. The university's multidisciplinary teams of researchers and clinicians collaborate to conduct rigorous and ethical studies, leveraging cutting-edge technologies and methodologies to address critical health challenges. Through its dedication to fostering an environment of inquiry and discovery, Yale University plays a pivotal role in translating research findings into clinical practice, ultimately enhancing health outcomes for diverse populations.

Locations

New Haven, Connecticut, United States

New Haven, Connecticut, United States

Patients applied

0 patients applied

Trial Officials

Kitt Petersen, MD

Principal Investigator

Yale University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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