Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 9:56 PM
Study NCT ID:
NCT05476627
Status:
RECRUITING
Last Update Posted:
2022-08-16
First Post:
2022-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Factors and Multiomics Study of Chronic Kidney Disease Caused by Metabolic Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D033461', 'term': 'Hyperuricemia'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074062', 'term': 'Environmental Biomarkers'}], 'ancestors': [{'id': 'D015415', 'term': 'Biomarkers'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D001686', 'term': 'Biological Phenomena'}, {'id': 'D004784', 'term': 'Environmental Monitoring'}, {'id': 'D004781', 'term': 'Environmental Exposure'}, {'id': 'D004787', 'term': 'Environmental Pollution'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-12', 'studyFirstSubmitDate': '2022-07-25', 'studyFirstSubmitQcDate': '2022-07-26', 'lastUpdatePostDateStruct': {'date': '2022-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with End Stage Renal Disease', 'timeFrame': '3 years', 'description': 'End Stage Renal Disease'}, {'measure': 'Number of Participants with Adverse cardiovascular events', 'timeFrame': '3 years', 'description': 'Adverse cardiovascular events'}, {'measure': 'Number of Participants with all cause death', 'timeFrame': '3 years', 'description': 'All cause death'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with eGFR decline', 'timeFrame': '3 years', 'description': 'the decline of eGFR during follow-up'}, {'measure': 'Number of Participants with Complications of CKD', 'timeFrame': '3 years', 'description': 'The complications of CKD'}, {'measure': 'Life quality assessment with short form-36 (SF-36)', 'timeFrame': '3 years', 'description': "The SF-36 is a patient-reported instrument designed to assess overall health status; it is usually utilized to measure patients' quality of life and used primarily in research. Increasing SF-36 scores are indicative of improving health status."}, {'measure': 'Advanced Intelligence Assessment with Mini-Mental State Examination (MMSE)', 'timeFrame': '3 years', 'description': 'The MMSE is scored on a 30-point scale, with items that assess orientation (temporal and spatial; 10 points), memory (registration and recall; 6 points), attention/concentration (5 points), language (verbal and written; 8 points), and visuospatial function (1 point) . While different cutoff points have been used across studies, scores ≤23 are most commonly regarded as abnormal and indicative of cognitive impairment.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic kidney disease', 'metabolic diseases', 'biomarker', 'functional imaging techniques'], 'conditions': ['Chronic Kidney Diseases', 'Hypertension', 'Diabetes Mellitus', 'Hyperuricemia', 'Obesity']}, 'descriptionModule': {'briefSummary': "With the development of China's economy, people's living standard have improved, and the dietary structure have changed. Metabolic diseases, such as hypertension, diabetes, hyperuricemia and obesity have gradually become an important health burden in China. The pathophysiological mechanism of renal injury caused by metabolic diseases has always been a hotspot of research. Currently, it is believed that various mechanisms including the activation of Renin-Angiotensin-Aldosterone System, vascular endothelial dysfunction, oxidative stress and inflammatory process may be involved. Although there are differences in renal pathological manifestations caused by different metabolic diseases, the kidney will eventually present ischemic changes and fibrosis with the progression of the disease. So there must be some common pathogenesis. This study is designed to build a disease cohort of patients with chronic kidney disease caused by metabolic diseases, to identify risk factors leading to disease progression and to explore biomarkers for early diagnosis and treatment of kidney damage."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population is consecutively enrolled from outpatient and inpatient department of our hospital.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The diagnosis of metabolic diseases were confirmed;\n* Be able to understand the process of the research;\n* Volunteer for participation and be able to sign the informed consent.\n\nExclusion Criteria:\n\n* Age \\<18 yrs or \\>80yrs;\n* Patients with primary and secondary glomerular diseases\n* Patients with other comorbidities that could affect the volume or the components of the kidney, such as renal cysts, polycystic kidney disease, medullary sponge kidney, hydronephrosis, renal artery stenosis, renal vein thrombosis and/or renal tumors;\n* Contraindications for MRI examination;\n* Pregnant or lactation patients;\n* Patients with unstable vital signs, failure of other organs or dysphoria.'}, 'identificationModule': {'nctId': 'NCT05476627', 'briefTitle': 'Risk Factors and Multiomics Study of Chronic Kidney Disease Caused by Metabolic Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Risk Factors and Multiomics Study of Chronic Kidney Disease Caused by Metabolic Diseases', 'orgStudyIdInfo': {'id': 'JS-2136'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hypertension Group', 'interventionNames': ['Diagnostic Test: Biomarkers']}, {'label': 'Diabetes Group', 'interventionNames': ['Diagnostic Test: Biomarkers']}, {'label': 'Hyperuricemia', 'interventionNames': ['Diagnostic Test: Biomarkers']}, {'label': 'Obesity', 'interventionNames': ['Diagnostic Test: Biomarkers']}], 'interventions': [{'name': 'Biomarkers', 'type': 'DIAGNOSTIC_TEST', 'description': 'Blood,urine and imaging biomarkers for early diagnosis and prediction of prognosis.', 'armGroupLabels': ['Diabetes Group', 'Hypertension Group', 'Hyperuricemia', 'Obesity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yan Liu', 'role': 'CONTACT', 'email': 'liuyanpumch@163.com', 'phone': '+86-15811568692'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yan Liu', 'role': 'CONTACT', 'email': 'liuyanpumch@163.com', 'phone': '+86-15811568692'}], 'overallOfficials': [{'name': 'Limeng Chen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'De-privatized data are to be shared with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'director of the department of nephrology', 'investigatorFullName': 'Limeng Chen', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}