Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2025-12-29 @ 12:43 AM
Study NCT ID:
NCT04570735
Status:
COMPLETED
Last Update Posted:
2024-12-17
First Post:
2020-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MRI Biomarkers in Diabetic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003928', 'term': 'Diabetic Nephropathies'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-01-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-12', 'studyFirstSubmitDate': '2020-09-18', 'studyFirstSubmitQcDate': '2020-09-24', 'lastUpdatePostDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between morphometric and functional and metabolic biomarker data obtained by magnetic resonance spectroscopy (MRS) in 3 different patient groups', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'Association between MRS biomarkers and annual glomerural filtration rate slope calculated within 3 previous years', 'timeFrame': '3 years'}, {'measure': 'Correlation between metabolic MRS biomarkers and urine and plasma metabolites quantification.', 'timeFrame': '1 month'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obesity', 'diabetic nephropathies', 'biomarkers', 'metabolites'], 'conditions': ['Diabetic Nephropathies']}, 'descriptionModule': {'briefSummary': 'Diabetic kidney disease is one of the most severe and frequent complications of diabetes. Few preclinical markers are available apart from plasma creatinine and microalbuminuria. These markers are imperfect (some patients with advanced renal disease do not have an increase in markers) and late. Therefor there is an uncovered need to identify complementary biomarkers. Magnetic Resonance Spectroscopy (MRS) is a Magnetic Resonance Imaging (MRI) technique that allows the physiology and biochemistry of human body tissues to be studied in a non-invasive and non-irradiating manner.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with type 2 diabetes with or without diabetic kidney disease and patients with obesity and no diabetes', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCommon to all 3 category\n\n* Male or female,\n* Age≥ 35 years,\n* Subject free, with legal protection guardianship or curatorship;\n* Enrollment in the French Social Security system;\n* Informed consent signed by the patient\n\nObese patients\n\n* BMI \\>30 kgm² ;\n* With no known diabetes;\n* estimated glomerular filtration rate (eGFR) \\> 60 ml/min/1.73m² and urine albumin-creatinin ratio (ACR) \\< 3 mg/g\n\nType 2 diabetic patients without kidney disease\n\n\\- eGFR \\> 60 ml/min/1.73m² AND ACR \\< 3 mg/g,\n\nType 2 diabetic patients with diabetic kidney disease defined as eGFR 30 to 60 ml/min/1.73m² OR ACR \\> 30 mg/mmol.\n\nExclusion Criteria:\n\nAge \\< 35 years History of kidney transplant Any contraindication to an MRI examination Legal protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, persons residing in a health or social establishment, adults under legal protection and finally patients in emergency situations Pregnant or lactating women, women of childbearing age who do not have effective contraception'}, 'identificationModule': {'nctId': 'NCT04570735', 'acronym': 'MR3T - DKD', 'briefTitle': 'MRI Biomarkers in Diabetic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Poitiers University Hospital'}, 'officialTitle': 'MRI Biomarkers in Diabetic Kidney Disease', 'orgStudyIdInfo': {'id': '2019-A02750-57'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with type 2 diabetes and diabetic kidney disease', 'interventionNames': ['Diagnostic Test: MRI']}, {'label': 'patients with type 2 diabetes and no diabetic kidney disease', 'interventionNames': ['Diagnostic Test: MRI']}, {'label': 'patients with obesity, no diabetes and no kidney disease', 'interventionNames': ['Diagnostic Test: MRI']}], 'interventions': [{'name': 'MRI', 'type': 'DIAGNOSTIC_TEST', 'description': 'MRI', 'armGroupLabels': ['patients with obesity, no diabetes and no kidney disease', 'patients with type 2 diabetes and diabetic kidney disease', 'patients with type 2 diabetes and no diabetic kidney disease']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Poitiers', 'country': 'France', 'facility': 'CHU de Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poitiers University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}