Time-restricted Eating for Patients With Type 2 Diabetes
A Pragmatic Clinical Trial of Time-restricted Eating in the University of Kentucky Barnstable Brown Diabetes Center
2 other identifiers
interventional
102
1 country
1
Brief Summary
This is a single-arm pragmatic clinical trial of time-restricted eating in patients with type 2 diabetes. Patients will be recruited from the University of Kentucky Barnstable Brown Diabetes Center. Subjects will participate in a 10-hour time-restricted eating intervention for 1-year.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable type-2-diabetes
Started Apr 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2025
CompletedFirst Posted
Study publicly available on registry
January 5, 2026
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
February 24, 2026
February 1, 2026
1.2 years
December 22, 2025
February 20, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Hemoglobin A1c
HbA1c data will be gathered from patient charts from routine labs collected during clinic visits.
At least 2 timepoints between baseline and 1 year. Since labs will depend on clinic visits, exact timeframe will vary.
Secondary Outcomes (2)
Change in Pittsburgh Sleep Quality Index
Baseline, 6 months, and 1 year
Change in Short Form-36 Quality of Life questionnaire scores
Baseline, 6 months, and 1 year
Study Arms (1)
Time-restricted eating
EXPERIMENTALSubjects in this group will consume all daily calories within a 10-h window during the day for 1-year.
Interventions
Subjects will consume all daily calories within a 10-hour (10h +/- 1hr) window during the daytime, ending by 8:00pm. Subjects will text the time of their first and last daily calorie intake for the duration of the study.
Eligibility Criteria
You may qualify if:
- Diagnosis of Type 2 Diabetes
You may not qualify if:
- Pregnant or breastfeeding
- Diagnosed eating disorder
- Night shift worker
- Taking drugs which induce hypoglycemia
- Unable or unwilling to participate in the time-restricted eating intervention
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Kentucky Barnstable Brown Diabetes Center
Lexington, Kentucky, 40504, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matt Thomas, PhD
University of Kentucky
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 22, 2025
First Posted
January 5, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
February 24, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share