RecruitingNot ApplicableNCT05365529
Time-Restricted Eating for Type II Diabetes: TRE-T2D
Feasibility and Efficacy of Time-Restricted Eating in Diabetes Management
Sponsor
University of California, San Diego
Enrollment
60 participants
Start Date
May 16, 2022
Study Type
INTERVENTIONAL
Conditions
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 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).
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria9
- 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 Criteria29
- 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).
- 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).
Interventions
BEHAVIORALTime-Restricted Eating
Participants in the TRE group with continue to follow their physicians treatment plan for type II diabetes mellitus and consume all of their food within an 8-10 hour eating window.
BEHAVIORALStandard of Care
Participants in the Standard of Care group will continue to follow their physician's treatment plan for type II diabetes mellitus.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05365529
Related Trials
A Randomized Comparison of Stage-Based Care Versus Risk Factor-Based Care for Prevention of Cardiovascular Events
NCT06112418115 locations
EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease
NCT070644731153 locations
Project Dulce for Arab Americans With Type 2 Diabetes
NCT055805362 locations
Improving Health Outcomes With Kefir
NCT066952211 location
The Cardiovascular Effect of GLP-1 Agonist, SGLT2 Inhibitor and Their Combination
NCT038787061 location