NCT05986097

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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P75+ for phase_1 type-2-diabetes

Timeline
Completed

Started Aug 2023

Longer than P75 for phase_1 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

August 2, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2025

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2025

Completed
Last Updated

November 21, 2025

Status Verified

November 1, 2025

Enrollment Period

2.2 years

First QC Date

July 17, 2023

Last Update Submit

November 17, 2025

Conditions

Type 2 Diabetes

Keywords

Very low carbohydrate dietNutrition therapy

Outcome Measures

Primary Outcomes (1)

  • Intervention satisfaction

    A 1-item measure about intervention satisfaction. We ask participants, "How would you rate your overall satisfaction with the program?" The item is rated from 1 = very dissatisfied to 6 = very satisfied, with higher scores reflecting greater satisfaction.

    At 4 months

Secondary Outcomes (5)

  • Weekly dietary adherence

    Weekly over 4 months

  • Change in diabetes treatment satisfaction

    0 to 4 months

  • Change in health-related quality of life

    0 to 4 months

  • Change in HbA1c

    0 to 4 months

  • Change in anti-hyperglycemic medications

    0 to 4 months

Study Arms (1)

Very low-carbohydrate breakfast

EXPERIMENTAL

Materials will encourage eating a very low-carbohydrate breakfast (or first meal of the day), with no more than about 5-10 non-fiber (net) grams of carbohydrates each.

Behavioral: Breakfast

Interventions

BreakfastBEHAVIORAL

We will provide participants recipes and information to support this dietary change.

Very low-carbohydrate breakfast

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HbA1c 7% or higher
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

  • Hansen A, Raymond K, Simon A, Kim S, Bayandorian H, Marriott D, Saslow LR. Very Low-Carbohydrate Breakfast Intervention for Adults with Type 2 Diabetes and Persistent Hyperglycemia: Protocol for a Digital, Nonrandomized Pre-Post Study. JMIR Res Protoc. 2026 Jan 28;15:e81041. doi: 10.2196/81041.

    PMID: 41605502DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Breakfast

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

MealsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Masking Details
Blood tests and continuous glucose monitoring are masked.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All participants will be provided the same intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 17, 2023

First Posted

August 14, 2023

Study Start

August 2, 2023

Primary Completion

October 9, 2025

Study Completion

October 17, 2025

Last Updated

November 21, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)