NCT06884059 Time Restricted Eating in Patients With Microalbuminuria
| NCT ID | NCT06884059 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of California, San Diego |
| Condition | Type 2 Diabetes Mellitus (T2DM) |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2026-07 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 25 participants in total. It began in 2026-07 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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).
Contact & Investigator
Pam Taub, MD
PRINCIPAL INVESTIGATOR
University of California, San Diego Health
Frequently Asked Questions
Who can join the NCT06884059 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Type 2 Diabetes Mellitus (T2DM). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06884059 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06884059 currently recruiting?
Yes, NCT06884059 is actively recruiting participants. Contact the research team at preventivecvresearch@health.ucsd.edu for enrollment information.
Where is the NCT06884059 trial being conducted?
This trial is being conducted at La Jolla, United States.
Who is sponsoring the NCT06884059 clinical trial?
NCT06884059 is sponsored by University of California, San Diego. The principal investigator is Pam Taub, MD at University of California, San Diego Health. The trial plans to enroll 25 participants.
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