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Time Restricted Eating in Patients With Microalbuminuria

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The proposed study aims to address the unmet medical need of treating microalbuminuria, particularly in patients with diabetes, through a prospective single-arm intervention lasting twelve weeks."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether eating within the same 8–10 hours each day can help the kidneys filter blood better. It is for adults with type 2 diabetes and higher levels of protein in their urine. Everyone in the study will follow this eating schedule.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Ages 18–75, with type 2 diabetes, and able to stand and walk without help.
  • A1c, a measure of average blood sugar, between 6.5% and 9.0%, with stable medicine doses.
  • Urine albumin-to-creatinine ratio, a urine protein test, from 30–300 mg.
  • eGFR, a measure of how well the kidneys filter blood, above 45.
  • Willing to use an Apple or Android smartphone and log enough eating information in the mCC app.
  • Usually eat over a period of at least 12 hours each day.
  • If able to become pregnant, take a pregnancy test at enrollment and use birth control during the study.
  • If taking heart, cholesterol, or blood pressure medicines, keep doses unchanged during the study. GLP-1 diabetes medicine doses must be stable for at least 3 months.

Who can't join

  • Type 1 diabetes, use of insulin or sulfonylurea diabetes medicines, or A1c above 9%. Pregnancy or breastfeeding also rules out joining.
  • Kidney filtering score below 45, or below 50 using the study’s MDRD calculation; stage 4 or 5 kidney disease; or dialysis treatment.
  • Blood pressure above 160 for the top number or 110 for the bottom number; LDL cholesterol above 200 mg/dL; or triglycerides, another blood fat, above 500 mg/dL.
  • Current tobacco or illegal drug use; a weight-loss program or special prescribed diet; recent weight-loss or appetite-lowering medicine unless the dose has been stable for 3 months; or past eating disorders or weight-loss surgery.
  • A major heart or blood vessel event within the past year, such as a heart attack, heart procedure, hospital stay for heart failure, stroke, or mini-stroke; or an uncontrolled abnormal heartbeat.
  • Treatment for an active inflammatory or rheumatic disease; active cancer treatment, except for non-melanoma skin cancer; serious liver damage; adrenal gland disease; HIV/AIDS; or thyroid medicine dose changes within the past 3 months.
  • An uncontrolled mental health condition, including a history of hospital care for mental illness.
  • Changing work shifts, including night shifts; frequent nighttime care for a dependent; or more than one planned trip to a time zone over 3 hours away.

Simplified for readability. The official criteria below are what the study team uses.

Official 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).

Study sites (1)

CA