The Breakfast Study

Description

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. The investigators will measure acceptability and feasibility, plus critical efficacy outcomes, such as changes in HbA1c, anti-hyperglycemic medications, glycemic variability, body weight, blood pressure, and lipids.

Conditions

Type 2 Diabetes

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Study Overview

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Study Details

Study overview

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. The investigators will measure acceptability and feasibility, plus critical efficacy outcomes, such as changes in HbA1c, anti-hyperglycemic medications, glycemic variability, body weight, blood pressure, and lipids.

The Breakfast Study: A Small Steps, Low-literacy, Breakfast-focused Dietary Self-management Intervention for Adults With Poorly Controlled Type 2 Diabetes

The Breakfast Study

Condition
Type 2 Diabetes
Intervention / Treatment

-

Contacts and Locations

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * HbA1c 8% 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
  • * 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

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Michigan,

Study Record Dates

2025-10-15