[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584032":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":58,"collaborators":60,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":20,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":89,"whyStopped":20,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"University of California, San Diego","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Time Restricted Eating (TRE) Group","EXPERIMENTAL","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.",[13],"Behavioral: Time Restricted Eating",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BEHAVIORAL","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.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Pam Taub, MD","University of California, San Diego Health","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Gavin C McLaren, BA","CONTACT","(858) 246-2342","preventivecvresearch@health.ucsd.edu",{"name":33,"role":29,"phone":34,"phoneExt":20,"email":31},"Marissa Dzotsi, BS, MPH","(858) 246-2715",[36],{"facility":37,"status":20,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Altman Clinical and Translational Research Institute","La Jolla","California","92093","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-117.2742,32.84727,{"lat":47,"lon":46},[50,54,57],{"name":51,"role":29,"phone":52,"phoneExt":20,"email":53},"Gavin McLaren","8582462342","g2mclaren@health.ucsd.edu",{"name":55,"role":29,"phone":34,"phoneExt":20,"email":56},"Fatima Abubaker Abdalla Abdelmajid, MBBS","fabdelmajid@health.ucsd.edu",{"name":23,"role":25,"phone":20,"phoneExt":20,"email":20},{"type":25,"investigatorFullName":23,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Pam Taub, MD, Professor of Medicine",[61],{"name":62,"class":6},"Salk Institute for Biological Studies","100584032","phase-1-time-restricted-eating-in-patients-with-microalbuminuria-100584032",false,"NCT06884059","Time Restricted Eating in Patients With Microalbuminuria","Impact of Time-Restricted Eating (TRE) on Kidney Health (The TREK Study)","TREK","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\u002Fday 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) \\\u003C 45\n3. Systolic BP greater than 160 mmHg and\u002For Diastolic BP greater than 110 mmHg (with or without treatment\u002Fmedication)\n4. LDL cholesterol greater than 200 mg\u002FdL\n5. Triglycerides greater than 500 mg\u002FdL\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 \\\u003C50mL\u002Fmin\u002F1.73m2\n14. Treatment for active inflammatory and\u002For 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\u002Ftransient ischemic attack (TIA).\n16. History of Uncontrolled arrhythmia (i.e., rate-controlled atrial fibrillation\u002Fatrial flutter are not exclusion criteria) 18. Liver cirrhosis and\u002For 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\u002Fsleep 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\u002Ftransient 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\u002FAIDS.\n27. Uncontrolled psychiatric disorder (including history of hospitalization for psychiatric illness).","ALL","18 Years","75 Years",{"count":75,"type":76},25,"ESTIMATED","INTERVENTIONAL",[79],"PHASE1","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.",[82,17,83],"Type 2 Diabetes Mellitus (T2DM)","Microalbuminuria",[83,17,85,86,87,88],"Urine Albumin-to-Creatinine Ratio","Type 2 Diabetes","uACR","Fasting","NOT_YET_RECRUITING","2025-03-12",{"date":92,"type":93},"2025-03-19","ACTUAL",{"date":95,"type":76},"2025-03",{"date":97,"type":76},"2028-02",{"name":5,"class":6},1]