Time-restricted Eating for Patients With Type 2 Diabetes

June 30, 2026 updated by: Justin (Matt) Thomas

A Pragmatic Clinical Trial of Time-restricted Eating in the University of Kentucky Barnstable Brown Diabetes Center

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Recruiting
        • University of Kentucky Barnstable Brown Diabetes Center
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of Type 2 Diabetes

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Time-restricted eating
Subjects in this group will consume all daily calories within a 10-h window during the day for 1-year.
Behavioral: Time-restricted eating
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hemoglobin A1c
Time Frame: At least 2 timepoints between baseline and 1 year. Since labs will depend on clinic visits, exact timeframe will vary.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pittsburgh Sleep Quality Index
Time Frame: Baseline, 6 months, and 1 year
Sleep quality will be measured using the Pittsburgh Sleep Quality Index and will be reported as a composite score ranging from 0 to 21 with a higher score indicating worse sleep quality.
Baseline, 6 months, and 1 year
Change in Short Form-36 Quality of Life questionnaire scores
Time Frame: Baseline, 6 months, and 1 year
Quality of life will be collected using the Short Form-36 Quality of Life questionnaire and scores for 8 scales will be analyzed: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Scores for each scale will range from 0 to 100 with higher scores indicating more favorable health.
Baseline, 6 months, and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Justin (Matt) Thomas

Collaborators

University of Kentucky Barnstable Brown Diabetes and Obesity Center

Investigators

  • Principal Investigator: Matt Thomas, PhD, University of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

December 22, 2025

First Submitted That Met QC Criteria

December 22, 2025

First Posted (Actual)

January 5, 2026

Study Record Updates

Last Update Posted (Actual)

July 2, 2026

Last Update Submitted That Met QC Criteria

June 30, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 105493
  • Funding Organization (Other Identifier: University of Kentucky Barnstable Brown Diabetes and Obesity Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes

Clinical Trials on Time-restricted eating

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe