Type 2 Diabetes (T2D) Clinical Trials

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Impact of Time-Restricted Eating (TRE) on Kidney Health (The TREK Study)

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This is a clinical trial to assess how time-restricted eating (TRE) may improve kidney health and filtration patients with type 2 diabetes and increased protein content in their urine. All participants will be participating in TRE in which they follow a consistent 8-10 hour eating window everyday.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Age: 18-75 years old

• Participants with T2DM with A1c between 6.5 and 9.0 % and on stable doses of medications who are weight-bearing and self-ambulatory.

• uACR ( urine albumin creatinine ratio) results ≥ 30 - 300 mg.

• Willingness to use smartphone for research procedures (Apple iOS or Android OS)

• Baseline eating period ≥12 hours/day and sufficient logging on the mCC app.

• Person of childbearing potential will be given a pregnancy test on study enrollment and asked to use contraception throughout the study.

• Post-menopausal and individuals on hormone replacement therapy will be included.

• Estimated Glomerular Filtration Rate (EGFR) \> 45

• 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

⁃ Participants on stable doses (consistent dose for ≥3 months) of GLP-1 receptor agonists will be included.

Locations
United States
California
Altman Clinical and Translational Research Institute
RECRUITING
La Jolla
Contact Information
Primary
Gavin C McLaren, BA
preventivecvresearch@health.ucsd.edu
(858) 246-2342
Backup
Marissa Dzotsi, MPH
preventivecvresearch@health.ucsd.edu
(858) 246-2715
Time Frame
Start Date: 2026-07
Estimated Completion Date: 2028-02
Participants
Target number of participants: 25
Treatments
Experimental: Time Restricted Eating (TRE) Group
Participants will limit the number of hours they eat in a dat to an 8-10 window and will also receive the standard heath and nutritional wellness guidelines. They will also be required to log food entries through the use of a smartphone app. Patients will also be required to wear a continuous glucose monitor (CGM) for the first and last two weeks of the 14 trial.
Related Therapeutic Areas
Sponsors
Collaborators: Salk Institute for Biological Studies
Leads: University of California, San Diego

This content was sourced from clinicaltrials.gov