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Calorie cutting may reverse a key step toward diabetes

NCT ID NCT02193295

Disease control Sponsor: Yale University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study investigates whether reducing calories to lower fat in the liver and muscles can improve how the body responds to insulin. Researchers will measure changes in insulin sensitivity and fat levels in 250 healthy but insulin-resistant adults with a family history of type 2 diabetes. Participants follow a calorie-restricted diet with weekly check-ins, and results are compared before and after the intervention.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
caloric restriction
What this could lead to
If successful, this approach could point toward a non-drug way to reverse insulin resistance and reduce the risk of type 2 diabetes and fatty liver disease.
What could go wrong
This is a small, early-stage study focused on biological markers, not long-term health outcomes. Results may not apply to everyone, and maintaining weight loss can be challenging.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2002

Expected to finish

Dec 2034

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 90 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Insulin Resistance metabolic dysfunction-associated steatotic liver disease pinta disease Weight Loss

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Insulin resistance NAFLD

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Magnetic Resonance Research Center (MRRC)

    ENROLLING_BY_INVITATION

    New Haven, Connecticut, 06511, United States

  • Yale Center for Clinical Investigation HRU

    RECRUITING

    New Haven, Connecticut, 06520, United States

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