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Study on Caloric Restriction for Insulin Resistance and NAFLD

This study is looking at whether a special diet called Caloric Restriction can help people with insulin resistance (when your body doesn't use insulin properly) and NAFLD (non-alcoholic fatty liver disease). The goal is to see if reducing the amount of fat in the liver and muscles, with only a small amount of weight loss, can improve how your body uses insulin. Researchers will measure your insulin sensitivity (how well your body responds to insulin) over up to 6 months to see if it gets better. You might be able to join if you are between 18 and 90 years old, healthy, don't smoke, and aren't taking most medications. You also need to have a hematocrit (a measure of red blood cells) above 35% and no history of diabetes or eating disorders. The study plans to enroll 250 people, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific intervention (Caloric Restriction). It aims to enroll 250 participants, but the phase and whether it's randomized or blinded are not specified.
What's involved
You will have weekly visits for measurements of body weight, body composition, blood glucose, and MRS (Magnetic Resonance Spectroscopy) measurements of liver and muscle fat. There will also be a 3-hour triple tracer study and muscle biopsies.
Compensation
Not stated in the trial record.
Follow-up
Improvements in insulin sensitivity will be measured for up to 6 months during the intervention period.

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NCT02193295

Reversal of Lipid-Induced Insulin Resistance

Recruiting
NAAges 18–90InterventionalBasic science
Yale University
~250 participants
Updated 2026-06-22 on ClinicalTrials.gov
What's tested:Caloric Restriction

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Improvements in insulin sensitivity
Measured over up to 6 months intervention to examine whether insulin sensitivity has improved significantly after the moderate weight reduction

Conditions

Insulin Resistance
NAFLD

Explore related trials

Insulin ResistanceNonalcoholic Fatty Liver Disease

Where it's being run

2 sites across 1 states
Connecticut2

Study leadership

  • Kitt Petersen, MD · PRINCIPAL_INVESTIGATOR · Yale University

Who to contact

Kitt Petersen, MD
[email protected]
203-785-5447
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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.

What this trial measures

  • Improvements in insulin sensitivityup to 6 months intervention to examine whether insulin sensitivity has improved significantly after the moderate weight reduction

    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.