Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-25 @ 7:18 PM
Study NCT ID:
NCT03512132
Status:
RECRUITING
Last Update Posted:
2024-07-19
First Post:
2018-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-18', 'studyFirstSubmitDate': '2018-04-11', 'studyFirstSubmitQcDate': '2018-04-18', 'lastUpdatePostDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ability to induce cholesterol efflux', 'timeFrame': 'inclusion', 'description': 'amount of cholesterol captured from cells expressed as %.'}, {'measure': 'Nitric oxide synthesis', 'timeFrame': 'inclusion', 'description': 'variation in the presence of HDL compared to the basal state, i.e. in the absence of HDL'}, {'measure': 'Anti-inflammatory effect', 'timeFrame': 'inclusion', 'description': 'variation in the expression of adhesion molecules (VCAM-1 \\[vascular cell adhesion molecule 1\\], ICAM-1 \\[InterCellular Adhesion Molecule 1\\] and E selectin) under the influence of TNF-alpha \\[Tumor Necrosis Factor alpha\\] in the presence of HDL compared to the absence of HDL.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': 'A number of arguments suggest that the deterioration in high density lipoproteins (HDL) functioning may worsen with the development of nephropathy during type 1 diabetes (T1D).\n\nThe objective of this study will be to investigate to what extent nephropathy in T1D patients in the microalbuminuria and macroalbuminuria stages, compared to T1D patients without nephropathy, is associated with an alteration in HDL functionality and changes in HDL size and composition (lipids with detailed study of phosphates and sphingolipids, main lipoproteins, inflammatory markers).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients treated in the Endocrinology, Diabetology or Nephrology departments of the CHU Dijon Bourgogne or in local nephrology or diabetology practices', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nINCLUSION CRITERIA GROUP C (CONTROLS) :\n\n* age \\> 18 years\n* a person who has given oral consent\n* Non-diabetics\n* Fasting plasma glucose \\< 6.10 mmol/L (1.1 g/L)\n* Triglyceridemia \\< 1.7 mmol/L (1.5 g/l)\n* HDL-C concentration \\> 1.30 mmol/L (for women and 1.03 mmol/L for men)\n* Glomerular filtration flow rate \\> 90 mL/min/1.73m2 (These thresholds correspond to the standard thresholds for these parameters)\n\nINCLUSION CRITERIA GROUP T1D-N (WITH NORMAL ALBUMINURIA) :\n\n* age \\> 18 years\n* a person who has given oral consent\n* Diabetic type 1 (based on the patient's clinical history and/or the presence of anti-glutamate decarboxylase autoantibodies and/or plasma C-peptide less than 0.5 ng/l)\n* HbA1c between 6 and 9%.\n* normal albuminuria (albumin/creatinine ratio \\< 2.5 mg/mmol in men and \\< 3.5 in women)\n* glomerular filtration rate \\> 90 mL/min/1.73m2\n\nINCLUSION CRITERIA GROUP T1D-MICRO (WITH MICROALBUMINURIA)\n\n* age \\> 18 years\n* a person who has given oral consent\n* Diabetic type 1 (based on the patient's clinical history and/or the presence of anti-glutamate decarboxylase autoantibodies and/or plasma C-peptide less than 0.5 ng/l)\n* HbA1c between 6 and 9%.\n* Microalbuminuria (albumin/creatinine ratio \\> 2.5 mg/mmol in men and \\> 3.5 in women, and \\< 30 mg/mmol)\n* glomerular filtration rate \\> 90 mL/min/1.73m2\n\nINCLUSION CRITERIA GROUP T1D-MACRO (WITH MACROALBUMINURIA)\n\n* age \\> 18 years\n* a person who has given oral consent\n* Diabetic type 1 (based on the patient's clinical history and/or the presence of anti-glutamate decarboxylase autoantibodies and/or plasma C-peptide less than 0.5 ng/l)\n* HbA1c between 6 and 9%.\n* Macroalbuminuria (albumin/creatinine ratio \\> 30 mg/mmol)\n* glomerular filtration rate \\> 45 mL/min/1.73m2\n\nExclusion Criteria:\n\n* Protected adult\n* Patient not affiliated to a social security scheme\n* Pregnant or breastfeeding woman\n* Drugs interfering with lipid metabolism outside insulin for DT1 : hypolipidemic (only for patients included in the DT1-micro group), corticosteroid, estroprogestogens, retinoic acid, antiproteases.\n* BMI \\> 30 kg/m2"}, 'identificationModule': {'nctId': 'NCT03512132', 'acronym': 'DID&NEPHRO', 'briefTitle': 'Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy', 'orgStudyIdInfo': {'id': 'DUVILLARD 2017'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'control', 'interventionNames': ['Biological: Blood samples', 'Biological: Urine sample']}, {'label': 'T1D with normal albumin levels', 'interventionNames': ['Biological: Blood samples', 'Biological: Urine sample']}, {'label': 'T1D with macroalbuminuria', 'interventionNames': ['Biological: Blood samples', 'Biological: Urine sample']}, {'label': 'T1D with microalbuminuria', 'interventionNames': ['Biological: Blood samples', 'Biological: Urine sample']}, {'label': 'T1D with microalbuminuria and statins', 'interventionNames': ['Biological: Blood samples', 'Biological: Urine sample']}], 'interventions': [{'name': 'Blood samples', 'type': 'BIOLOGICAL', 'description': '5 EDTA tubes of 7ml and 1 dry tube of 7 ml taken on an empty stomach', 'armGroupLabels': ['T1D with macroalbuminuria', 'T1D with microalbuminuria', 'T1D with microalbuminuria and statins', 'T1D with normal albumin levels', 'control']}, {'name': 'Urine sample', 'type': 'BIOLOGICAL', 'description': 'Urine sample on an empty stomach', 'armGroupLabels': ['T1D with macroalbuminuria', 'T1D with microalbuminuria', 'T1D with microalbuminuria and statins', 'T1D with normal albumin levels', 'control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Dijon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurence DUVILLARD', 'role': 'CONTACT', 'email': 'laurence.duvillard@chu-dijon.fr', 'phone': '03.80.29.34.53'}], 'facility': 'Chu Dijon Bourogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}