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16-Hour daily fast tested as diabetes therapy

NCT ID NCT07272460

Disease control Sponsor: Mount Sinai Hospital, Canada 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether time-restricted eating—fasting for 18 hours and eating only during a 6-hour window each day—can help preserve the pancreas's ability to produce insulin and improve blood sugar control in people with type 2 diabetes. Over 52 weeks, 112 overweight adults will either follow this eating schedule or standard lifestyle advice. The goal is to see if this simple dietary change can slow diabetes progression.

What this could mean

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

Active substance
time-restricted eating (behavioral intervention)
What this could lead to
If it works, this could point toward a simple, drug-free way to help preserve insulin production and improve blood sugar control in early type 2 diabetes.
What could go wrong
This is a mid-sized trial (112 people) testing a behavioral change, which can be hard to stick with long-term. Results may not apply to everyone, and the benefit might be modest.

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 112 people

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

Started

Feb 2026

Expected to finish

Jul 2029

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 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Individuals with previously diagnosed BMI ≥ 25 kg/m2 and type 2 diabetes within preceding 10 years. * Age 18 - 75 years inclusive * Stable weight over past 12 weeks (less than 5% change in body weight) (self-reported) * Diabetes treatment consisting of lifestyle only or metformin, dipeptidyl peptidase-4 (DPP-4) inhibitor, and sodium-glucose co-transporter 2 (SGLT2) inhibitors either as monotherapy or in combination. * Ability to read and understand English Exclusion Criteria: * Current diabetes treatment with insulin, glucagon-like peptide-1 receptor agonists, and/or sulfonylureas. * Use of any other pharmacological treatment for weight-loss * Previous surgical treatment for weight loss such as gastric bypass or gastric band * Any history of eating disorder * Currently pregnant or lactating * Renal dysfunction as evidenced by estimated glomerular filtration rate \< 25 ml/min by CKD-EPI Creatinine Equation * New York Heart Association class II-IV heart failure * Hepatic disease considered to be clinically significant (includes jaundice, chronic hepatitis, or previous liver transplant) or transaminases \>2.5X the upper limit of normal * Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer) * Any other factor likely to limit adherence to the study, in the opinion of the investigators * Concurrent participation in another research study relevant to diabetes and metabolic health

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Conditions

The condition(s) this trial relates to.

Intermittent Fasting Overweight type 2 diabetes mellitus

As listed by the trial registrant

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

Overweight (bmi > 25) Type 2 diabetes

How to take part

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

  1. The places running it

    1 site. 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

  • Leadership Sinai Centre for Diabetes

    RECRUITING

    Toronto, Ontario, M5T3L9, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.