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Breakfast makeover: simple diet change may tame diabetes

NCT ID NCT05986097

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 02, 2026 · Updated 3 times

Summary

This study tested a 4-month online program that encourages a very low-carbohydrate breakfast for adults with poorly controlled type 2 diabetes. Researchers measured how satisfied participants were, how well they stuck to the diet, and changes in blood sugar, weight, and medication use. The goal is to see if this simple breakfast change is a practical way to improve 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
low-carbohydrate breakfast-focused dietary program
What this could lead to
If successful, this could offer a simple, low-cost dietary approach to help manage type 2 diabetes and reduce medication needs.
What could go wrong
This is a small, early-phase trial (119 participants) focused on feasibility and satisfaction, not a large-scale test of effectiveness. Results may not apply to all people with diabetes.

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

119 people

The number who actually took part.

Started

Aug 2023

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

18 to 80 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: * HbA1c 7% or higher * 18-80 years old * The ability to understand verbal and written English * Willingness to follow the prescribed diet * Able to consent and follow directions * Willingness to regularly check blood glucose levels as required Exclusion Criteria: * Inability to provide informed consent * Pregnant, breastfeeding, or planning for either in the next 6 months or \<6 months postpartum * Low C-peptide and possible subsequent GAD 65 level that suggests type 1 diabetes, clinical factors that suggest type 1 diabetes (lean, lack of family history, and diabetic ketoacidosis in the past) or a previous diagnosis of type 1 diabetes or latent autoimmune diabetes * Triglycerides are greater than 999mg/dL on the screening blood draw * Cancer, heart failure, or kidney failure * Vegan * Untreated mental health condition * Currently following a very low-carbohydrate diet or breakfasts * Thyroid levels out of range * Alcoholism * Previous bariatric surgery * Difficulty chewing or swallowing * Dependence on others for food preparation * Currently enrolled in another investigative study that might conflict with this research

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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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