Time-restricted Eating for Patients With Type 2 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Time-restricted eating.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Pragmatic Clinical Trial of Time-restricted Eating in the University of Kentucky Barnstable Brown Diabetes Center
Overview
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
- 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.
Primary outcome measures
- 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.]
Secondary outcome measures (2)
- Change in Pittsburgh Sleep Quality Index [Time frame: Baseline, 6 months, and 1 year]
- Change in Short Form-36 Quality of Life questionnaire scores [Time frame: Baseline, 6 months, and 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Kentucky Barnstable Brown Diabetes Center — Lexington
Identifiers
NCT: NCT07318207 · 105493 · Funding Organization