NCT05986097Completed
The Breakfast Study
The Breakfast Study: A Small Steps, Low-literacy, Breakfast-focused Dietary Self-management Intervention for Adults With Poorly Controlled Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
The investigators conducted an acceptability, feasibility, preliminary effectiveness trial of a 4-month, online, very low-carbohydrate breakfast-focused program in 120 adults with type 2 diabetes. The investigators measured acceptability and feasibility, plus critical efficacy outcomes, such as changes in HbA1c, anti-hyperglycemic medications, glycemic variability, body weight, blood pressure, and lipids.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 119 (actual)
- First submitted
- 17 Jul 2023
- Start date
- 2 Aug 2023
- Primary completion date
- 9 Oct 2025
- Lead sponsor
- University of Michigan
- Diseases
- Type 2 diabetes
- NCT number
- NCT05986097
What you commit to
- Study type: Interventional
- Participants enrolled: 119
- From 2 Aug 2023 to the primary completion date, 9 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Previous bariatric surgery
Other illness
- Cancer, heart failure, or kidney failure
- Untreated mental health condition
Other
- Inability to provide informed consent
- Pregnant, breastfeeding, or planning for either in the next 6 months or \<6 months postpartum
- Triglycerides are greater than 999mg/dL on the screening blood draw
- Vegan
- Currently following a very low-carbohydrate diet or breakfasts
- Thyroid levels out of range
- Alcoholism
- Difficulty chewing or swallowing
- Dependence on others for food preparation
- Currently enrolled in another investigative study that might conflict with this research
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.