Type 2 Diabetes
Conditions
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.
Interventions
BEHAVIORALTime-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.
Sponsors
Justin (Matt) Thomas
University of Kentucky Barnstable Brown Diabetes and Obesity Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin A1c | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Pittsburgh Sleep Quality Index | 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. |
| Change in Short Form-36 Quality of Life questionnaire scores | 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. |
Countries
United States
Contacts
CONTACTMatt Thomas, PhD
PRINCIPAL_INVESTIGATORMatt Thomas, PhD
University of Kentucky
Outcome results
None listed