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Can a Very-Low-Carb diet reverse prediabetes? trial puts it to the test

NCT ID NCT07830121

NEW Prevention Sponsor: Universiti Teknologi Mara Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers are testing whether a very-low-carbohydrate diet can help adults with prediabetes and obesity lose weight, reduce body fat, and improve insulin sensitivity. The trial enrolls adults aged 30 to 65 with obesity and newly diagnosed prediabetes. Participants are randomly assigned to follow either a very-low-carb diet (under 50 grams of carbs daily) or standard dietary advice for 12 weeks, with both groups receiving dietitian support. The study measures changes in weight, body composition, blood sugar, insulin, cholesterol, and kidney function to see if the low-carb approach works better and is safe to follow.

What this could mean

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

Active substance
a very-low-carbohydrate diet (under 50 grams of carbohydrate per day)
What this could lead to
If it works, this could give doctors and dietitians a clearer dietary option to help stop prediabetes from turning into type 2 diabetes.
What could go wrong
The trial is small and short, so any benefits may not last or apply to everyone. Very-low-carb diets can be hard to stick with, and the study does not yet show whether they work better than standard advice.

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

33 people

The number who actually took part.

Started

Jan 2024

Finished

Dec 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

30 to 65 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: * Age 30 to 65 years * Body mass index (BMI) 23-40 kg/m² * Diagnosis of prediabetes, defined as fasting blood glucose (FBG) 5.6-6.9 mmol/L or glycated haemoglobin (HbA1c) 5.6-6.2% * Able to stand independently * Able to provide written informed consent Exclusion Criteria: * Diagnosis of type 1 or type 2 diabetes mellitus * Calculated creatinine clearance \<60 mL/min/1.73 m² * on antiobesity medications * On medications that can interfere with glucose metabolism * Heart failure, New York Heart Association (NYHA) functional class III-IV * Active systemic inflammatory disease * Chronic kidney disease requiring haemodialysis * Active hepatic disease * Collagen vascular disease * Malignancy * Acute coronary syndrome within the preceding 3 months * Pregnancy or breastfeeding * Plans to conceive within the following year

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Conditions

The condition(s) this trial relates to.

Insulin Resistance Obesity obesity disorder Overweight prediabetes syndrome Weight Loss type 2 diabetes mellitus prevention target

As listed by the trial registrant

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

Obesity / overweight Prediabetes Very low carbohydrate diet

Contacts and locations

Locations

  • Hospital UITM

    Sungai Buloh, Selangor, 47000, Malaysia

More trials for these conditions

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