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Keto diet battles plate method for diabetes control

NCT ID NCT05237128

Disease control Sponsor: University of Michigan 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compared two diets for people with type 2 diabetes: a very low-carbohydrate (keto) diet and a plate-method diet. Over 12 months, researchers tracked blood sugar control and body composition in 182 participants. The goal was to see which approach better improves diabetes management.

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 (keto) diet and plate-method diet
What this could lead to
If successful, this could show that a keto diet is better than a standard plate-method diet for managing blood sugar and body composition in type 2 diabetes.
What could go wrong
This is a completed study with 182 participants, so results are limited in size. Dietary studies rely on self-reporting, and individual results may vary. The keto diet can be hard to stick with long-term.

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

182 people

The number who actually took part.

Started

Mar 2022

Finished

Oct 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 years and older

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: * diagnosis of type 2 diabetes, with current HbA1c \> 6.5% and \< 12% (self-reported and then measured at screening) * ability to speak English (this is a group-based intervention) * ability to engage in light physical activity * willingness to be randomized to either type of diet Exclusion Criteria: * unable to provide informed consent * substance abuse, mental health, cognitive, or medical condition that would, in the opinion of the investigators, make it difficult for the individual to take part in the intervention, may alter key outcomes, or may require important diet modifications and includes conditions such as hypercalcemia or thyroid dysfunction * pregnant or planning to become pregnant in the next 12 months, or currently breastfeeding (pregnancy and breastfeeding require modifications to the intervention's dietary approaches) * current use of weight loss medications (this is likely to alter weight outcomes and may alter other measures) * history of weight loss (bariatric) surgery or plans for bariatric surgery in the next year * currently enrolled in a weight loss program or have unalterable plans to enroll in one of these programs in the next year * vegan or vegetarian * unwilling or unable to participate in study measurements and group classes * current use of systemic steroids (self-reported in screening survey; oral or IV systemic steroids excluded. Injected steroids may be permitted depending on frequency and timing of injections with regard to lab assessments (minimum of 2 weeks between injection and blood tests)) * weight above 400 pounds (weight limit for dual-energy X-ray absorptiometry (DEXA) scans) * history of multiple or recent (within the last four years) kidney stones * currently following a very low-carbohydrate diet * unwilling to stop an SGLT2 inhibitor medication if the participant were to be randomized to the very low-carbohydrate diet

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

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

Type 2 diabetes

Contacts and locations

Locations

  • The University of California San Francisco (UCSF)

    San Francisco, California, 94143, United States

  • University of MIchigan

    Ann Arbor, Michigan, 48109, United States

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