Not Yet RecruitingPhase 1

Time Restricted Eating in Patients With Microalbuminuria

United States25 participantsStarted 2025-03

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. Participants with Type1DM and T2DM who are taking insulin, sulfonylureas, or have an HbA1c \> 9 %.
✕. Estimated Glomerular Filtration Rate (EGFR) \< 45
✕. 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

What they're measuring

Urine albumin-to-creatinine ratio (uACR)

Timeframe: Baseline and 3 months

Trial details

NCT IDNCT06884059

SponsorUniversity of California, San Diego

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-02

Contact for this trial

Gavin C McLaren, BA

(858) 246-2342 preventivecvresearch@health.ucsd.edu

View on ClinicalTrials.gov More Type 2 Diabetes Mellitus (T2DM) trials