Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-24 @ 2:55 PM
Study NCT ID:
NCT06884059
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-19
First Post:
2025-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Time Restricted Eating in Patients With Microalbuminuria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D000093763', 'term': 'Intermittent Fasting'}, {'id': 'D005215', 'term': 'Fasting'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-12', 'studyFirstSubmitDate': '2025-03-05', 'studyFirstSubmitQcDate': '2025-03-12', 'lastUpdatePostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Anti-inflammatory effects of TRE', 'timeFrame': 'Baseline and 3 months', 'description': 'Hypothesis-generating exploration and measure of anti-inflammatory effects of TRE assessed by plasma inflammatory cytokine levels.'}, {'measure': 'Time in Range', 'timeFrame': 'Baseline and 3 months', 'description': 'Change in the time spent within the target glucose range, as assessed by Continuous Glucose Monitoring (CGM) from interstitial glucose.'}, {'measure': 'Glycemic Variability', 'timeFrame': 'Baseline and 3 months', 'description': 'Change in glycemic variability, as assessed by Continuous Glucose Monitoring (CGM) from interstitial glucose.'}, {'measure': 'Mean Glucose', 'timeFrame': 'Baseline and 3 months', 'description': 'Change in mean glucose levels, as assessed by Continuous Glucose Monitoring (CGM) from interstitial glucose.'}], 'primaryOutcomes': [{'measure': 'Urine albumin-to-creatinine ratio (uACR)', 'timeFrame': 'Baseline and 3 months', 'description': 'Change in uACR (mg/g) assessed via urine sample'}], 'secondaryOutcomes': [{'measure': 'Glycemic regulation assessed by Continuous Glucose Monitor (CGM)', 'timeFrame': 'Baseline and 3 months', 'description': 'Change in glycemic regulation as assessed by CGM from interstitial glucose with various outcomes measured.'}, {'measure': 'Fasting glucose levels (mg/dL)', 'timeFrame': 'Baseline and 3 months', 'description': 'Change in glycemic regulation as assessed fasting plasma glucose (mg/dL).'}, {'measure': 'Glycemic regulation assessed by HbA1c', 'timeFrame': 'Baseline and 3 months', 'description': 'Change in blood glucose assessed via hemoglobin A1c.'}, {'measure': 'Blood pressure', 'timeFrame': 'Baseline and 3 months', 'description': 'Change in blood pressure assessed by sphygmomanometer.'}, {'measure': 'LDL-Cholesterol', 'timeFrame': 'Baseline and 3 months', 'description': 'Changes in atherogenic lipids assessed via LDL-Cholesterol.'}, {'measure': 'Non-HDL Cholesterol (nmol/mol)', 'timeFrame': 'Baseline and 3 months', 'description': 'Changes in atherogenic lipids assessed via LDL-Cholesterol.'}, {'measure': 'Triglycerides (mg/dL)', 'timeFrame': 'Baseline and 3 months', 'description': 'Changes in atherogenic lipids assessed via Triglycerides (mg/dL).'}, {'measure': 'Quality of life Assessment via Short Form-36 Questionnaire (SF-36)', 'timeFrame': 'Baseline and 3 months', 'description': 'Changes in quality of life will be assessed using the SF-36 questionnaire, with scores ranging from 0 to 100, where higher scores indicate better health outcomes.'}, {'measure': 'Sleep Quality Assessment via Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'Baseline and 3 months', 'description': 'Changes in sleep quality will be assessed using the PSQI questionnaire, which evaluates sleep quality over the past month. The PSQI produces a global score ranging from 0 to 21, with higher scores indicating worse sleep quality'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Microalbuminuria', 'Time Restricted Eating', 'Urine Albumin-to-Creatinine Ratio', 'Type 2 Diabetes', 'uACR', 'Fasting'], 'conditions': ['Type 2 Diabetes Mellitus (T2DM)', 'Time Restricted Eating', 'Microalbuminuria']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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. Microalbuminuria, indicative of abnormal glomerular capillary permeability, serves as an early marker for renal impairment and heightened cardiovascular risk. The study hypothesizes that adherence to time-restricted eating (TRE) over the intervention period will significantly reduce microalbuminuria levels, as assessed by the urine albumin-to-creatinine ratio (uACR). Unlike other methods, uACR provides an estimation of 24-hour urine albumin excretion and is unaffected by variations in urine concentration, eliminating the need for timed specimens or 24-hour collections. If successful, this study could highlight the potential of TRE as a non-invasive and accessible dietary intervention for managing microalbuminuria and related conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: 18-75 years old\n2. Participants with T2DM with A1c between 6.5 and 9.0 % and on stable doses of medications who are weight-bearing and self-ambulatory.\n3. uACR ( urine albumin creatinine ratio) results ≥ 30 - 300 mg.\n4. Willingness to use smartphone for research procedures (Apple iOS or Android OS)\n5. Baseline eating period ≥12 hours/day and sufficient logging on the mCC app.\n6. Person of childbearing potential will be given a pregnancy test on study enrollment and asked to use contraception throughout the study.\n7. Post-menopausal and individuals on hormone replacement therapy will be included.\n8. Estimated Glomerular Filtration Rate (EGFR) \\> 45\n9. 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\n10. Participants on stable doses (consistent dose for ≥3 months) of GLP-1 receptor agonists will be included.\n\nExclusion Criteria:\n\n1. Participants with Type1DM and T2DM who are taking insulin, sulfonylureas, or have an HbA1c \\> 9 %.\n2. Estimated Glomerular Filtration Rate (EGFR) \\< 45\n3. Systolic BP greater than 160 mmHg and/or Diastolic BP greater than 110 mmHg (with or without treatment/medication)\n4. LDL cholesterol greater than 200 mg/dL\n5. Triglycerides greater than 500 mg/dL\n6. Active tobacco or illicit drug use\n7. Pregnant or breastfeeding individuals.\n8. Currently enrolled in a weight-loss or weight-management program,\n9. Currently on a special or prescribed diet for other reasons (e.g., Celiac disease),\n10. 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 ).\n11. History of eating disorder(s).\n12. History of surgical intervention for weight management (e) active eating disorder.\n13. Chronic kidney disease with an eGFR calculated based on the Modification of Diet in Renal Disease (MDRD) equation \\<50mL/min/1.73m2\n14. Treatment for active inflammatory and/or rheumatologic disease and cancer.\n15. 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).\n16. 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\n17. 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.\n18. Caregivers for dependents requiring frequent nocturnal care/sleep interruptions.\n19. More than one trip planned to travel to a time zone with greater than a 3-hour difference during study period.\n20. 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)).\n21. 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).\n22. History of adrenal disease.\n23. History of malignancy undergoing active treatment, except non-melanoma skin cancer.\n24. Known history of type I diabetes.\n25. History of stage 4 or 5 chronic kidney disease or requiring dialysis.\n26. History of HIV/AIDS.\n27. Uncontrolled psychiatric disorder (including history of hospitalization for psychiatric illness).'}, 'identificationModule': {'nctId': 'NCT06884059', 'acronym': 'TREK', 'briefTitle': 'Time Restricted Eating in Patients With Microalbuminuria', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Impact of Time-Restricted Eating (TRE) on Kidney Health (The TREK Study)', 'orgStudyIdInfo': {'id': '810456'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Time Restricted Eating (TRE) Group', 'description': '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.', 'interventionNames': ['Behavioral: Time Restricted Eating']}], 'interventions': [{'name': 'Time Restricted Eating', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Time Restricted Eating (TRE) Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Gavin McLaren', 'role': 'CONTACT', 'email': 'g2mclaren@health.ucsd.edu', 'phone': '8582462342'}, {'name': 'Fatima Abubaker Abdalla Abdelmajid, MBBS', 'role': 'CONTACT', 'email': 'fabdelmajid@health.ucsd.edu', 'phone': '(858) 246-2715'}, {'name': 'Pam Taub, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Altman Clinical and Translational Research Institute', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}], 'centralContacts': [{'name': 'Gavin C McLaren, BA', 'role': 'CONTACT', 'email': 'preventivecvresearch@health.ucsd.edu', 'phone': '(858) 246-2342'}, {'name': 'Marissa Dzotsi, BS, MPH', 'role': 'CONTACT', 'email': 'preventivecvresearch@health.ucsd.edu', 'phone': '(858) 246-2715'}], 'overallOfficials': [{'name': 'Pam Taub, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'collaborators': [{'name': 'Salk Institute for Biological Studies', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pam Taub, MD, Professor of Medicine', 'investigatorFullName': 'Pam Taub, MD', 'investigatorAffiliation': 'University of California, San Diego'}}}}