Time Restricted Eating in Patients With Microalbuminuria
NCT ID: NCT06884059
Last Updated: 2025-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
25 participants
INTERVENTIONAL
2025-03-31
2028-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Time Restricted Eating (TRE) Group
Participants will limit the number of hours they eat in a dat to an 8-10 window and will also receive the standard heath and nutritional wellness guidelines. They will also be required to log food entries through the use of a smartphone app. Patients will also be required to wear a continuous glucose monitor (CGM) for the first and last two weeks of the 14 trial.
Time Restricted Eating
Participants in the TRE group with continue to follow their physicians treatment plan for type II diabetes mellitus and consume all of their food within an 8-10 hour eating window.
Interventions
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Time Restricted Eating
Participants in the TRE group with continue to follow their physicians treatment plan for type II diabetes mellitus and consume all of their food within an 8-10 hour eating window.
Eligibility Criteria
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Inclusion Criteria
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
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).
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).
18 Years
75 Years
ALL
No
Sponsors
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Salk Institute for Biological Studies
OTHER
University of California, San Diego
OTHER
Responsible Party
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Pam Taub, MD
Pam Taub, MD, Professor of Medicine
Principal Investigators
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Pam Taub, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego Health
Locations
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Altman Clinical and Translational Research Institute
La Jolla, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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810456
Identifier Type: -
Identifier Source: org_study_id
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