Weight loss to improve insulin sensitivity in insulin-resistant individuals

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates whether a small weight loss can reduce lipid content in muscle and liver, thereby improving insulin sensitivity in lean, insulin-resistant individuals with a family history of type 2 diabetes. Participants will undergo a series of metabolic assessments, including glucose metabolism and lipolysis measurements, before and after a caloric restriction intervention. The study aims to compare these effects with a control group of individuals without a family history of diabetes, using advanced techniques such as euglycemic hyperinsulinemic clamps and magnetic resonance spectroscopy.

Why it matters

Who can join: the full rules

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's running

• Yale Center for Clinical Investigation HRU
  New Haven, Connecticut, United States Recruiting
• Magnetic Resonance Research Center (MRRC)
  New Haven, Connecticut, United States Enrolling by invitation

Study contacts

• Principal investigator: Kitt Petersen, MD — Yale University
• Study coordinator: Kitt Petersen, MD
• Email: kitt.petersen@yale.edu
• Phone: 203-785-5447

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.