Actively Recruiting
Time-Restricted Eating for Type II Diabetes: TRE-T2D
Led by University of California, San Diego · Updated on 2024-10-08
60
Participants Needed
1
Research Sites
197 weeks
Total Duration
On this page
Sponsors
U
University of California, San Diego
Lead Sponsor
S
Salk Institute for Biological Studies
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a randomized clinical trial to assess the feasibility and efficacy of time-restricted eating (TRE) to improve glucose regulation and cardiovascular health of participants with type 2 diabetes mellitus (T2DM). Participants will be randomized into 2 groups: 1) standard of care (SOC), in which they will continue to follow their physician's treatment plan, or 2) SOC and TRE (8-10 hours eating window).
CONDITIONS
Official Title
Time-Restricted Eating for Type II Diabetes: TRE-T2D
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years old
- Patients with type 2 diabetes mellitus (T2DM) with Hemoglobin A1c (A1c) between 6.5% and 9.0% on stable medication doses
- Weight-bearing and able to walk independently
- Own a smartphone (Apple iOS or Android)
- Baseline eating period of at least 12 hours per day and able to log food intake sufficiently on the myCircadianClock app
- Women of childbearing age must have a negative pregnancy test at enrollment and use contraception during the study
- Post-menopausal women and women on hormone replacement therapy are eligible
- Estimated Glomerular Filtration Rate (EGFR) greater than 30 mL/min/1.73m2
- If taking cardiovascular medications (such as statins, lipid-modifying drugs, or anti-hypertensives), doses must remain stable during the study
- Patients on stable doses of GLP-1 receptor agonists are included
You will not qualify if you...
- Participants with type 1 diabetes or type 2 diabetes taking insulin or sulfonylureas
- Hemoglobin A1c greater than 9%
- Body Mass Index (BMI) over 50 kg/m2
- Systolic blood pressure over 160 mmHg or diastolic blood pressure over 110 mmHg
- LDL cholesterol over 200 mg/dL
- Triglycerides over 500 mg/dL
- Active tobacco or illicit drug use
- Pregnant or breastfeeding women
- Currently enrolled in weight-loss or weight-management programs
- On special or prescribed diets for other medical reasons (e.g., celiac disease)
- Recently started (within 3 months) medications for weight loss or appetite suppression
- History of eating disorders or surgical weight management
- Chronic kidney disease with EGFR less than 30 mL/min/1.73m2
- Treatment for active inflammatory, rheumatologic diseases, or cancer
- Major cardiovascular events within past 6 months
- Uncontrolled arrhythmia (except rate-controlled atrial fibrillation/flutter)
- Liver cirrhosis or significant liver dysfunction
- Thyroid disease requiring recent dose changes
- Known inflammatory or rheumatologic disease
- Shift workers with variable hours including night shifts
- Caregivers needing frequent nighttime care duties
- Planned travel across time zones exceeding 3 hours during study
- Major cardiovascular events within past year
- History of adrenal disease
- Active cancer treatment except non-melanoma skin cancer
- Known history of HIV/AIDS
- Uncontrolled psychiatric disorders including previous psychiatric hospitalization
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Altman Clinical and Translational Research Institute
La Jolla, California, United States, 92093
Actively Recruiting
Research Team
J
Justina P Nguyen, BS
CONTACT
D
David T Van, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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