Status:
NOT_YET_RECRUITING
Time Restricted Eating in Patients With Microalbuminuria
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
Salk Institute for Biological Studies
Conditions:
Type 2 Diabetes Mellitus (T2DM)
Time Restricted Eating
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 participant...
Detailed Description
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. Micr...
Eligibility Criteria
Inclusion
- 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
- 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
- Participants on stable doses (consistent dose for ≥3 months) of GLP-1 receptor agonists will be included.
Exclusion
- 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
- Active tobacco or illicit drug use
- Pregnant or breastfeeding individuals.
- Currently enrolled in a weight-loss or weight-management program,
- Currently on a special or prescribed diet for other reasons (e.g., Celiac disease),
- 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 ).
- History of eating disorder(s).
- History of surgical intervention for weight management (e) active eating disorder.
- Chronic kidney disease with an eGFR calculated based on the Modification of Diet in Renal Disease (MDRD) equation \<50mL/min/1.73m2
- Treatment for active inflammatory and/or rheumatologic disease and cancer.
- 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).
- 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
- 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.
- Caregivers for dependents requiring frequent nocturnal care/sleep interruptions.
- More than one trip planned to travel to a time zone with greater than a 3-hour difference during study period.
- 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)).
- 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).
- History of adrenal disease.
- History of malignancy undergoing active treatment, except non-melanoma skin cancer.
- Known history of type I diabetes.
- History of stage 4 or 5 chronic kidney disease or requiring dialysis.
- History of HIV/AIDS.
- Uncontrolled psychiatric disorder (including history of hospitalization for psychiatric illness).
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06884059
Start Date
March 1 2025
End Date
February 1 2028
Last Update
March 19 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Altman Clinical and Translational Research Institute
La Jolla, California, United States, 92093