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NCT Number: NCT07318207

Time-restricted Eating for Patients With Type 2 Diabetes

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky Barnstable Brown Diabetes Center

Lexington, Kentucky, 40504, United States

Location status: Recruiting

Location contact

Matt Thomas, PhD

CONTACT

[email protected]

859-562-0642

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Time-restricted eating

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Matt Thomas, PhD

CONTACT

[email protected]

859-562-0642

Sponsors and collaborators

Lead sponsor

Justin (Matt) Thomas

Other

Collaborators

  • University of Kentucky Barnstable Brown Diabetes and Obesity Center

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 5, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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