Time-restricted eating for people with type 2 diabetes and microalbuminuria
Official title: Impact of Time-Restricted Eating (TRE) on Kidney Health (The TREK Study)
Run by University of California, San Diego · NCT06884059 · Data updated 2026-11-12
This study tests whether following an 8–10 hour daily eating window can improve kidney health in adults with type 2 diabetes and microalbuminuria.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 25 (estimated) |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 1 site (La Jolla, California) |
| Status | Recruiting |
| Started | July 2026 |
| Main results expected | February 2027 |
| Study ends | February 2028 |
| Registry record updated | July 14, 2026 |
| Trial ID | NCT06884059 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–75 with type 2 diabetes, stable medications, and uACR 30–300 mg/g.
✕Probably not a fit
People without microalbuminuria or with unstable medications or contraindications to time-restricted eating may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 1, single-arm interventional trial evaluating the effect of time-restricted eating on kidney health in adults with type 2 diabetes and elevated urine albumin-to-creatinine ratio. Participants will adhere to a consistent 8–10 hour daily eating window for twelve weeks, with monitoring of kidney function and uACR to assess potential changes. The study uses uACR as a practical marker of urinary protein excretion and aims to determine whether TRE can reduce microalbuminuria without requiring 24-hour urine collections. Eligible adults must have T2DM, an uACR of 30–300 mg/g, stable medications, and the ability to log eating windows via a smartphone app. The trial is conducted at UC San Diego with Salk Institute collaboration, led by the Altman Institute site in La Jolla.
Why it matters
Potential benefit: If successful, TRE could offer a non-pharmacologic option to reduce microalbuminuria and support kidney health in people with type 2 diabetes.
How similar studies have gone: Previous research suggests dietary patterns can influence kidney markers, but this exact TRE approach for microalbuminuria in diabetes is exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age: 18-75 years old 2. Participants with T2DM with A1c between 6.5 and 9.0 % and on stable doses of medications who are weight-bearing and self-ambulatory. 3. uACR ( urine albumin creatinine ratio) results ≥ 30 - 300 mg. 4. Willingness to use smartphone for research procedures (Apple iOS or Android OS) 5. Baseline eating period ≥12 hours/day and sufficient logging on the mCC app. 6. Person of childbearing potential will be given a pregnancy test on study enrollment and asked to use contraception throughout the study. 7. Post-menopausal and individuals on hormone replacement therapy will be included. 8. Estimated Glomerular Filtration Rate (EGFR) \> 45 9. 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 10. Participants on stable doses (consistent dose for ≥3 months) of GLP-1 receptor agonists will be included. Exclusion Criteria: 1. Participants with Type1DM and T2DM who are taking insulin, sulfonylureas, or have an HbA1c \> 9 %. 2. Estimated Glomerular Filtration Rate (EGFR) \< 45 3. Systolic BP greater than 160 mmHg and/or Diastolic BP greater than 110 mmHg (with or without treatment/medication) 4. LDL cholesterol greater than 200 mg/dL 5. Triglycerides greater than 500 mg/dL 6. Active tobacco or illicit drug use 7. Pregnant or breastfeeding individuals. 8. Currently enrolled in a weight-loss or weight-management program, 9. Currently on a special or prescribed diet for other reasons (e.g., Celiac disease), 10. On recently prescribed medication that is meant for weight loss, or has known effect on appetite suppression ( patient on stable dose for 3 months can be enrolled ). 11. History of eating disorder(s). 12. History of surgical intervention for weight management (e) active eating disorder. 13. Chronic kidney disease with an eGFR calculated based on the Modification of Diet in Renal Disease (MDRD) equation \<50mL/min/1.73m2 14. Treatment for active inflammatory and/or rheumatologic disease and cancer. 15. 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). 16. History of Uncontrolled arrhythmia (i.e., rate-controlled atrial fibrillation/atrial flutter are not exclusion criteria) 18. Liver cirrhosis and/or significant alterations in liver function 17. 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), Shift workers with variable (e.g., nocturnal) hours. 18. Caregivers for dependents requiring frequent nocturnal care/sleep interruptions. 19. More than one trip planned to travel to a time zone with greater than a 3-hour difference during study period. 20. 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)). 21. 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). 22. History of adrenal disease. 23. History of malignancy undergoing active treatment, except non-melanoma skin cancer. 24. Known history of type I diabetes. 25. History of stage 4 or 5 chronic kidney disease or requiring dialysis. 26. History of HIV/AIDS. 27. Uncontrolled psychiatric disorder (including history of hospitalization for psychiatric illness).
Where it's running
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Altman Clinical and Translational Research Institute
La Jolla, California, United States Recruiting
Study contacts
- Principal investigator: Pam Taub, MD — University of California, San Diego Health
- Study coordinator: Gavin C McLaren, BA
- Email: preventivecvresearch@health.ucsd.edu
- Phone: (858) 246-2342
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.