A program focusing on very low-carbohydrate breakfasts for adults with type 2 diabetes
The Breakfast Study: A Small Steps, Low-literacy, Breakfast-focused Dietary Self-management Intervention for Adults With Poorly Controlled Type 2 Diabetes
This study is testing an online program that encourages adults with type 2 diabetes to eat very low-carbohydrate breakfasts for four months to see if it helps them manage their blood sugar and weight more easily.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT05986097 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the acceptability and feasibility of a 4-month online program that promotes a very low-carbohydrate breakfast for adults with type 2 diabetes. The study will involve 120 participants who will be monitored for changes in key health metrics such as HbA1c levels, body weight, and medication use. The program aims to simplify dietary changes to improve glycemic control without overwhelming participants with complex dietary instructions. By focusing on breakfast, the intervention seeks to make adherence easier, especially for those with lower health literacy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with an HbA1c level of 7% or higher who can understand and follow dietary instructions.
Not a fit: Patients with type 1 diabetes, certain medical conditions, or those currently following a very low-carbohydrate diet may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve blood sugar control and reduce the need for diabetes medications in patients with type 2 diabetes.
How similar studies have performed: Previous studies have shown that low-carbohydrate diets can effectively improve glycemic control in individuals with type 2 diabetes, suggesting a positive outlook for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * 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
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.