Health TrialsbyHealthPanel

Time-restricted Eating for Patients With Type 2 Diabetes

ConditionType 2 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJustin (Matt) Thomas

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of Type 2 Diabetes

Disqualifiers

Pregnant or breastfeeding

Diagnosed eating disorder

Night shift worker

Taking drugs which induce hypoglycemia

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

102 Participants
are divided into 1 treatment group
Group A: Time-restricted eatingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Hemoglobin A1c

HbA1c data will be gathered from patient charts from routine labs collected during clinic visits.

Time frame
At least 2 timepoints between baseline and 1 year. Since labs will depend on clinic visits, exact timeframe will vary.

Secondary outcomes

1

Change in Pittsburgh Sleep Quality Index

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.

Time frame
Baseline, 6 months, and 1 year
2

Change in Short Form-36 Quality of Life questionnaire scores

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.

Time frame
Baseline, 6 months, and 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Justin (Matt) Thomas

Lead sponsor

University of Kentucky

Sponsor institution

University of Kentucky Barnstable Brown Diabetes and Obesity Center

Collaborator

Source ClinicalTrials.gov
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