Feasibility and Efficacy of Time-Restricted Eating in Diabetes Management

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
Altman Clinical and Translational Research Institute
RECRUITING
La Jolla
Contact Information
Primary
Justina P Nguyen, BS
preventivecvresearch@health.ucsd.edu
858-246-2406
Backup
David T Van, BS
858-246-2342
Time Frame
Start Date: 2022-05-16
Estimated Completion Date: 2026-03
Participants
Target number of participants: 60
Treatments
Placebo_comparator: Standard of Care
The participants in this arm will receive the standard health and nutritional wellness guidelines and will be required to log food entries through the use of a smartphone app.
Experimental: Time-Restricted Eating
The participants in this arm will limit the number of hours they eat in day to a 8-10-hour window and will also receive the standard health and nutritional wellness guidelines. They will also be required to log food entries through the use of a smartphone app.
Authors
Related Therapeutic Areas
Sponsors
Collaborators: Salk Institute for Biological Studies
Leads: University of California, San Diego

This content was sourced from clinicaltrials.gov