[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"microalbuminuria\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:microalbuminuria":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,54,91],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":34,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100639290","new-taipei-city-888-digital-medical-ai-platform-for-prevention-and-care-of-the-three-highs-and-cardio-renal-vascular-diseases-100639290",false,"NCT07588256","New Taipei City 888 Digital Medical AI Platform for Prevention and Care of the Three Highs and Cardio-Renal-Vascular Diseases","New Taipei City 888 Digital Medical AI Platform for the Prevention and Treatment of the Three Highs (Hypertension, Hyperglycemia, Hyperlipidemia) and Cardio-Renal-Vascular Diseases: Validation and Implementation Through Large-Scale Cluster Randomized Clinical Trials: T-888-DIGICARE-DREAM","DIGICARE-DREAM","Inclusion Criteria:\n\nI.T-888-DIGICARE：\n\nEligible participants must meet the definition of hypertension and at least one of the following chronic (non-hypertensive) conditions:\n\n1. Hypertension\n\n   * With or without treatment, and meeting one of the following:\n   * Office blood pressure: two consecutive measurements \\>130\u002F80 mmHg\n   * Home blood pressure: weekly average (morning\u002Fevening) \\>130\u002F80 mmHg, or more than half of the weekly measurements exceeding this threshold\n2. Hyperlipidemia\n\n   * With or without treatment, and\n   * LDL-C \\>100 mg\u002FdL (or \\>70 mg\u002FdL in patients with diabetes or established ASCVD)\n3. Diabetes Mellitus\n\n   * With or without treatment, and\n   * HbA1c \\>6.5%\n4. Chronic Kidney Disease (CKD)\n\n   * Estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73 m², and\n   * Urine albumin-to-creatinine ratio (UACR) \\>30 mg\u002Fg\n5. Atherosclerotic Cardiovascular Disease (ASCVD):\n\n   * Including coronary artery disease, cerebrovascular disease, peripheral arterial disease, or aortic pathology\n\nII. DREAM-G:\n\n1. Hypertension\n\n   * With or without treatment, and meeting one of the following:\n   * Office blood pressure: two consecutive measurements \\>130\u002F80 mmHg\n   * Home blood pressure: weekly average (morning\u002Fevening) \\>130\u002F80 mmHg, or more than half of weekly measurements exceeding this threshold\n2. Hyperlipidemia\n\n   * With or without treatment, and\n   * LDL-C \\>100 mg\u002FdL (or \\>70 mg\u002FdL in patients with diabetes or established ASCVD)\n3. Diabetes Mellitus\n\n   * With or without treatment, and\n   * HbA1c \\>6.5%\n4. Chronic Kidney Disease (CKD)\n\n   * Estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73 m², and\n   * Measurable urinary microalbumin-to-creatinine ratio\n5. Atherosclerotic Cardiovascular Disease (ASCVD):\n\n   • Including coronary artery disease, cerebrovascular disease, peripheral arterial disease, or aortic pathology\n\n   Participants must meet at least one of the above chronic disease conditions and:\n6. Untreated Hypertension:\n\n   * Morning home blood pressure (HBP) \\>130\u002F80 mmHg: weekly average (≥4 days) \\>130\u002F80 mmHg,\n   * Or more than half of morning HBP measurements (≥4 days per week) \\>130\u002F80 mmHg\n7. Treated Hypertension:\n\n   * Morning home blood pressure \\>130\u002F80 mmHg: weekly average (≥4 days) \\>130\u002F80 mmHg,\n   * Or more than half of morning HBP measurements (≥4 days per week) \\>130\u002F80 mmHg\n   * Average home blood pressure ≤130\u002F80 mmHg (used to determine treatment strategy)\n\nExclusion Criteria:\n\nI. T-888-DIGICARE\n\n1. Symptomatic heart failure (New York Heart Association functional class II-IV)\n2. End-stage renal disease requiring long-term dialysis\n3. Pregnant women or those planning pregnancy\n\nII. DREAM-G:\n\n1. Life expectancy \\\u003C1 year\n2. End-stage renal disease (ESRD) requiring regular renal replacement therapy, including dialysis, kidney transplantation, or palliative care\n3. Severe liver cirrhosis\n4. Malignancy under active treatment","ALL",{"count":19,"type":20},4162,"ESTIMATED","INTERVENTIONAL",[23],"NA","Non-communicable diseases (NCDs), or chronic diseases, are a major public health burden globally and in Taiwan, and control of the \"three highs\" (hypertension, dyslipidemia, and hyperglycemia) is a national priority. Nearly half of the 10 leading causes of death in Taiwan are directly or indirectly related to atherosclerotic cardiovascular disease (ASCVD), for which hypertension, dyslipidemia, and abnormal blood glucose are the major risk factors. National health insurance data indicate that over 70% of middle-aged and older adults have at least one of these chronic conditions. Early stages are often asymptomatic, and inadequate control may lead to complications of cardiovascular disease, stroke, renal vascular disease, and retinopathy, causing irreversible organ damage and death.\n\nFor blood pressure, large clinical trials such as SPRINT and STEP have shown that targeting systolic blood pressure below 130 mmHg significantly reduces ASCVD events. For LDL cholesterol, \"the lower, the better\" applies, with guideline-recommended LDL-C targets determined by baseline ASCVD risk, with levels below 55 mg\u002FdL for very high-risk patients. For diabetes, treatment goals generally include fasting plasma glucose below 130 mg\u002FdL and glycated hemoglobin (HbA1c) below 7%.\n\nAlthough antihypertensive therapy has been proven effective in preventing cardiovascular disease and chronic kidney disease attributable to hypertension, fewer than one-third of patients receiving antihypertensive medications achieve current guideline-recommended blood pressure targets. No randomized clinical trial to date has used home blood pressure as the primary therapeutic reference. Moreover, long-term evidence is lacking regarding the organ-protective effects of strategies targeting morning hypertension and of bedtime dosing regimens. Although the TIME study is currently the largest and longest-followed trial addressing dosing time, its bedtime-dosing arm was not specifically targeted to patients with morning hypertension. Therefore, we propose a clinical trial to investigate management strategies for morning hypertension. Aligned with the 2022 Taiwan Hypertension Guidelines, we will employ the \"722 protocol\" for home blood pressure monitoring and enroll patients with morning home blood pressure ≥130\u002F80 mmHg to compare selective nocturnal administration of antihypertensive agents versus exclusive morning dosing, assessing differences in morning home blood pressure control rates, end-organ damage, and atherosclerotic cardiovascular disease (ASCVD) events.\n\nThis project will implement two large-scale cluster-randomized clinical trials within the New Taipei City healthcare network. The first trial (T-888-DIGICARE) will evaluate whether a mobile digital health platform augmented with interactive digital modules can more effectively achieve the \"888\" targets for prevention and treatment of the Three Highs (Hypertension, Hyperglycemia, Hyperlipidemia). The second trial (DREAM-G) will use the same mobile health delivery model to investigate whether the timing of antihypertensive medication administration (nocturnal versus morning dosing) differentially affects patients with poor morning home blood pressure control. Beyond generating rigorous evidence through a novel clinical approach, this program is expected to have substantial global clinical impact and to showcase Taiwan's healthcare capabilities internationally. Operational challenges encountered and solutions developed during the trials will also provide critical feasibility data for the concurrent real-world implementation registry (T-888-DIGICARE-Registry). The registry will run in parallel with the cluster trials and will enroll individuals who decline trial participation at baseline as well as participants after trial completion, thereby serving as a continuity and real-world evidence platform.",[26,27,28,29,30,31,32,33],"Microalbuminuria","Microalbuminuria \u002FCreatinine Ratios ACR","Cardiovascular Disease Risk Factor","Cardiovascular Disease Prevention","Digital Medicine","Hypertension","Hyperglycaemia (Diabetic)","Hyperlipidemia",[35,36,37,38,39,40],"digital medicine","hypertension","home blood pressure monitoring","dyslipidemia","microalbuminuria","diabetes","RECRUITING","2026-05-11",{"date":44,"type":45},"2026-05-14","ACTUAL",{"date":47,"type":45},"2026-02-05",{"date":49,"type":20},"2029-02-05",{"name":51,"class":52},"New Taipei City Medical Association","OTHER",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":17,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":21,"phases":66,"briefSummary":68,"conditions":69,"keywords":77,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":53},"100607373","phase-4-ace-reno-pico-cell-matrix-and-its-effect-on-egfr-in-chronic-kidney-diseases-100607373","NCT07187713","ACE Reno, Pico Cell Matrix and Its Effect on eGFR in Chronic Kidney Diseases","ACE Reno, Effect of Pico Cell Matrix on Patients With Micro-albuminuria, Proteinuria or CKD (of Any Degree) Due to Diabetes Mellitus, Autoimmune, Miscellaneous Aetiology","ACE Reno","Inclusion Criteria:\n\n* Adults (≥18 years) with nephropathy of any degree (microalbuminuria, overt proteinuria, CKD stages 1-5 not on dialysis, or post-transplant with proteinuria). Stable background therapy with ACEi\u002FARB, SGLT2i, or MRA allowed.\n\nExclusion Criteria:\n\n* Recent kidney transplant (\\\u003C12 months). Uncontrolled acute infection or unstable autoimmune disease. Pregnancy or lactation. Known hypersensitivity to study components.","18 Years","80 Years",{"count":65,"type":20},300,[67],"PHASE4","This study investigates the safety and efficacy of ACE Reno, an oral transmucosal solution containing standardized bioactive peptides and amino acids, in patients with nephropathy of various etiologies and stages. The trial evaluates whether 12 weeks of ACE Reno (1 mL sublingually four times daily) reduces albuminuria\u002Fproteinuria and stabilizes kidney function in participants with nephropathy due to diabetes, hypertension, autoimmune disease, reflux\u002FUTI, chronic glomerulonephritis, unknown etiology, pre-dialysis CKD, or post-transplant proteinuria.\n\nNephropathy remains a global health burden, with \\~9-10% of the population affected by chronic kidney disease (CKD), equating to \\>750 million individuals worldwide. The socioeconomic costs are substantial: in England CKD costs \\~£7 billion annually, projected to rise to \\~£14 billion by 2033; in Malaysia, prevalence rose from 9% to 15.5% within 7 years; in Egypt, CKD imposes heavy familial and financial burdens, especially for pediatric patients; in Turkey, CKD is among the top causes of disability, linked to the rising tide of diabetes, obesity, and hypertension.\n\nACE Reno is designed to address multiple drivers of CKD progression - glomerulosclerosis, fibrosis, endothelial dysfunction, and maladaptive RAAS\u002Faldosterone signaling - through its peptide components that mimic antifibrotic (BMP-7, HGF, Klotho-like) and vasodilatory\u002FcGMP-mediated (natriuretic peptide-like) pathways.",[70,71,72,73,74,75,26,76],"Hypertensive Nephropathy","Auto Immune Disorders","Chronic Kidney Disease","Chronc Kidney Disease Stage 5","Chronic Kidney Disease (Stage 3-4)","Chronic Kidney Disease (Stages 4 and 5)","Diabetic Nephropathies",[78,79,80],"chronic kidney disease","ckd","nephropathy","2025-09-19",{"date":83,"type":45},"2025-09-23",{"date":85,"type":20},"2025-09-20",{"date":87,"type":20},"2026-12-31",{"name":89,"class":90},"Ace Cells Lab Limited","INDUSTRY",{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":17,"minAge":62,"maxAge":99,"enrollmentInfo":100,"targetDuration":4,"studyType":21,"phases":102,"briefSummary":104,"conditions":105,"keywords":108,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":53},"100584032","phase-1-time-restricted-eating-in-patients-with-microalbuminuria-100584032","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).","75 Years",{"count":101,"type":20},25,[103],"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.",[106,107,26],"Type 2 Diabetes Mellitus (T2DM)","Time Restricted Eating",[26,107,109,110,111,112],"Urine Albumin-to-Creatinine Ratio","Type 2 Diabetes","uACR","Fasting","NOT_YET_RECRUITING","2025-03-12",{"date":116,"type":45},"2025-03-19",{"date":118,"type":20},"2025-03",{"date":120,"type":20},"2028-02",{"name":122,"class":52},"University of California, San Diego"]