Could a daily eating window shield kidneys in diabetes?

NCT ID NCT06884059

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Recruiting now This study
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Registered, but not yet taking participants.
By invitation only
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Paused for now. It may or may not start again.
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Running, but no longer taking on new participants.
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The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
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Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
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First seen Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This trial investigates whether time-restricted eating (TRE) — eating all food within an 8-10 hour window each day — can improve kidney function in people with type 2 diabetes who have elevated protein in their urine (microalbuminuria). All 25 participants follow the same TRE schedule while continuing their usual diabetes care. The study measures changes in urine albumin levels and blood sugar control over the intervention period.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
time-restricted eating (TRE) — consuming all food within an 8-10 hour daily window
What this could lead to
If it works, this could point toward a simple dietary strategy to protect kidney health in people with type 2 diabetes.
What could go wrong
This is a small, early-phase trial with only 25 participants and no control group, so results may not be generalizable. The effect on kidney function may be modest or absent.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

Fasting Intermittent Fasting type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The study's own enquiry address

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  2. The places running it

    1 site. The list below names each one and where it is.

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Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • Altman Clinical and Translational Research Institute

    RECRUITING

    La Jolla, California, 92093, United States

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