Status:
COMPLETED
The Breakfast Study
Lead Sponsor:
University of Michigan
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
The investigators will conduct an acceptability, feasibility, preliminary effectiveness trial of a 4-month, online, very low-carbohydrate breakfast-focused program in 120 adults with type 2 diabetes. ...
Detailed Description
More than 15% of U.S. adults with type 2 diabetes have poorly controlled blood gluocse, here defined as a glycated hemoglobin (HbA1c) level of 7.0% or higher. These adults have an elevated health risk...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 17 2025
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT05986097
Start Date
August 2 2023
End Date
October 17 2025
Last Update
November 21 2025
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109