NCT07318207

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

77
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
13mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress9%
Apr 2026Jun 2027

First Submitted

Initial submission to the registry

December 22, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 5, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

1.2 years

First QC Date

December 22, 2025

Last Update Submit

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

EXPERIMENTAL

Subjects in this group will consume all daily calories within a 10-h window during the day for 1-year.

Behavioral: Time-restricted eating

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.

Time-restricted eating

Eligibility Criteria

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

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

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Matt Thomas, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matt Thomas, PhD

CONTACT

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

Locations