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Can a very Low-Carb diet beat standard advice for prediabetes?

NCT ID NCT05235425

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 completed study compared two versions of the Diabetes Prevention Program in 304 overweight adults with prediabetes. One group followed the standard lower-calorie, lower-fat diet, while the other tried a very low-carbohydrate diet. Researchers measured changes in blood sugar control (HbA1c), weight, and inflammation over 12 months to see which approach works better for preventing type 2 diabetes.

What this could mean

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

Active substance
very low-carbohydrate diet
What this could lead to
If successful, this could point toward a more effective dietary approach for preventing type 2 diabetes in people with prediabetes.
What could go wrong
This is a completed study, but results are not yet widely reported. The low-carb diet may be harder to stick with long-term, and individual results can vary.

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

304 people

The number who actually took part.

Started

Mar 2022

Finished

Nov 2025

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

21 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: * overweight, defined as BMI \>= 25 kg/m2 \>= 23 kg/m2 if of Asian descent * HbA1c between 5.7% - 6.4% verified at baseline * willingness to participate in group-based sessions * able to engage in at least light physical activities such as walking * willingness to follow a prescribed diet, be randomized, self-weight, track diet, and report physical activity minutes * physician approval to participate Exclusion Criteria: * history of type 1 diabetes or type 2 diabetes * use of anti-obesity medications or participation in another weight loss program or intervention * use of glucose lowering medications other than metformin * pregnant or planning to become pregnant during the intervention period * breastfeeding * use of oral corticosteroids * previous bariatric surgery or planning to have bariatric surgery during the study period * blood disorders that influence HbA1c, including frequent blood transfusions, phlebotomy, anemia, hemoglobinopathy, polycythemia * any condition for which the study team deems participation to be unsafe or inappropriate * inability to read, write, or speak English * inability to provide informed consent * adherence to a vegan or vegetarian diet * adherence to a very low-carbohydrate (keto) diet * difficulty chewing or swallowing * no influence over what foods are purchased, prepared, and/or served * above weight limit for DEXA (500 pounds) * untreated eating disorder or mental health conditions, such as depression with suicidal ideation, bipolar or schizophrenia with psychosis * use of warfarin * chronic kidney disease, stage 4 or higher * use of loop diuretics: 20mg or higher of furosemide or equivalent (Lasix (furosemide), Bumex (bumetanide), Ederin or Sodium Edecrin (ethacrynic acid), Demadex or Soaanz (torsemide)) * any concerning values in baseline labs (participants will be referred to Primary Care Physician and will be allowed to return for later enrollment if labs are no longer concerning) * Triglycerides 600 Milligrams per deciliter (mg/dL) or higher * Thyroid stimulating hormone of any abnormal value * Potassium of any abnormal value

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

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