Status:
RECRUITING
Time-Restricted Eating for Type II Diabetes: TRE-T2D
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
Salk Institute for Biological Studies
Conditions:
Diabetes Mellitus, Type 2
Time Restricted Feeding
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
The intervention will last for 12 weeks with a follow-up assessment at 6 months. This study will deliver the intervention, monitor participant health for safety, and promote compliance through clinic ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Age: 18-75 years old
- Patients with T2DM with A1c between 6.5 and 9.0 % and on stable doses of medications who are weight-bearing and self-ambulatory.
- Own a smartphone (Apple iOS or Android OS)
- Baseline eating period ≥12 hours/day and sufficient logging on the mCC app.
- Women of childbearing age will be given a pregnancy test on study enrollment and asked to use contraception throughout the study.
- Post-menopausal and women on hormone replacement therapy will be included.
- Estimated Glomerular Filtration Rate (EGFR) \> 30mL/min/1.73m2
- If participants are on cardiovascular medications (HMG CoA reductase inhibitors (statins), other lipid-modifying drugs, anti-hypertensives) no dose adjustments will be allowed during the study period
- Patients on stable doses of GLP-1 receptor agonists will be included.
- Exclusion Criteria
- Participants with Type1DM and T2DM who are taking insulin, sulfonylureas, or have an HbA1c \> 9 %.
- BMI \> 50 kg/m2
- Systolic BP greater than 160 mmHg and/or Diastolic BP greater than 110 mmHg (with or without treatment/medication)
- LDL cholesterol greater than 200 mg/dL
- Triglycerides greater than 500 mg/dL
- Active tobacco or illicit drug use
- Pregnant or breastfeeding women.
- Currently enrolled in a weight-loss or weight-management program,
- Currently on a special or prescribed diet for other reasons (e.g., Celiac disease),
- The recent initiation, within the 3 preceding months prior to study enrollment, of medications designed for weight loss or with recognized appetite-suppressant effects (e.g. GLP-1 receptor agonists). Patients that are stable on such medications for at least 3 months can still be enrolled.
- History of eating disorder(s).
- History of surgical intervention for weight management (e) active eating disorder.
- Chronic kidney disease with an eGFR calculated based on the Modification of Diet in Renal Disease (MDRD) equation \< 30mL/min/1.73m2
- Treatment for active inflammatory and/or rheumatologic disease and cancer.
- A major adverse cardiovascular event within the past 6 months such as acute coronary syndrome (ACS), percutaneous coronary intervention, coronary artery bypass graft surgery, hospitalization for congestive heart failure, stroke/transient ischemic attack (TIA).
- History of Uncontrolled arrhythmia (i.e., rate-controlled atrial fibrillation/atrial flutter are not exclusion criteria)
- Liver cirrhosis and/or significant alterations in liver function
- History of (a) thyroid disease requiring dose titration of thyroid replacement medication(s) within the past 3 months (i.e., hypothyroidism on a stable dose of thyroid replacement therapy is not an exclusion),
- Known inflammatory and/or rheumatologic disease.
- Shift workers with variable (e.g., nocturnal) hours.
- Caregivers for dependents requiring frequent nocturnal care/sleep interruptions.
- More than one trip planned to travel to a time zone with greater than a 3-hour difference during study period.
- History of major adverse cardiovascular events within the past 1 year (acute coronary syndrome (ACS), percutaneous coronary intervention, coronary artery bypass graft surgery, hospitalization for congestive heart failure, stroke/transient ischemic attack (TIA)).
- History of thyroid disease requiring dose titration of thyroid replacement medication(s) within the past 3 months (i.e., hypothyroidism on a stable dose of thyroid replacement therapy is not an exclusion).
- History of adrenal disease.
- History of malignancy undergoing active treatment, except non-melanoma skin cancer.
- Known history of type I diabetes.
- History of stage 4 or 5 chronic kidney disease or requiring dialysis.
- History of HIV/AIDS.
- Uncontrolled psychiatric disorder (including history of hospitalization for psychiatric illness).
Exclusion
Key Trial Info
Start Date :
May 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05365529
Start Date
May 16 2022
End Date
March 1 2026
Last Update
October 8 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Altman Clinical and Translational Research Institute
La Jolla, California, United States, 92093