Can a very Low-Carb diet beat standard advice for prediabetes?
NCT ID NCT05235425
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
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304 people
The number who actually took part.
- Started
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Mar 2022
- Finished
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Nov 2025
- Lead sponsor
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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
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21 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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University of Michigan
Ann Arbor, Michigan, 48109, United States
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Other studies related to the condition(s) this trial covers.
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