Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-05-08 @ 9:17 PM
Study NCT ID:
NCT02862860
Status:
COMPLETED
Last Update Posted:
2024-02-21
First Post:
2016-07-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Search for a Link Between the Different Variables for Glycaemia and Oxidative Stress or Impaired HDL Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-19', 'studyFirstSubmitDate': '2016-07-28', 'studyFirstSubmitQcDate': '2016-08-10', 'lastUpdatePostDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average blood glucose', 'timeFrame': 'through study completion, an average of 7 days'}, {'measure': 'Time hypoglycemia', 'timeFrame': 'through study completion, an average of 7 days'}, {'measure': 'Time hyperglycemia', 'timeFrame': 'through study completion, an average of 7 days'}, {'measure': 'Amplitude of glycemic variations', 'timeFrame': 'through study completion, an average of 7 days'}]}, 'conditionsModule': {'conditions': ['Type-1 Diabetes']}, 'descriptionModule': {'briefSummary': 'As glycaemic variability on the one hand and hypoglycaemia on the other are associated with oxidative stress and inflammation, they are likely, in type-1 diabetic patients, to affect the oxidation of lipoproteins and HDL function, by altering their anti-atherogenic properties.\n\nThe aim of this study is thus to determine, in patients with Type 1 Diabetic (T1D) who will wear a glycaemic Holter for 1 week, the glycaemia parameters (mean glycaemia, duration of hypoglycaemia, duration of hyperglycaemia, mean amplitude of glycaemic excursions) associated with proatherogenic alterations in lipoproteins, in particular:\n\n* LDL oxidation\n* HDL oxidation and alterations of HDL function (anti-inflammatory capacity, antioxidant capacity)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have provided written consent\n* Patients with national health insurance cover\n\nPatients with T1D\n\n* T1D Patients treated with insulin via a pump or multiple injections\n* HbA1c \\< 9.5 %\n\nControl patients\n\n* Normal fasting glycaemia (\\< 6.1 mmol/L)\n* Age \\> 18 years, matched for sex and age with T1D patients\n\nAll patients\n\n* Normal serum HDL cholesterol (\\> 1.04 mmol/L in men, \\> 1.30 mmol:L in women)\n* Serum LDL cholesterol \\< 5 mmol/L\n* triglyceridemia \\< 1.7 mmol/L\n* Waist circumference \\< 102 cm in men, \\< 88 cm in women\n\nExclusion Criteria:\n\n* Smoking\n* Kidney failure (Creatinine clearance\\< 60 ml/min/1.73 m2)\n* Liver failure\n* Dysthyroidism\n* Medication that interferes with lipoprotein metabolism (lipid-lowering agents, oestroprogestative, anti-HIV, corticoids, retinoic acid), unless stopped for at least one 1 month\n* Antioxidant (vitamin E, dietary supplements, DHA)\n* Pregnancy of more than 15d'}, 'identificationModule': {'nctId': 'NCT02862860', 'acronym': 'Holter Gly', 'briefTitle': 'Search for a Link Between the Different Variables for Glycaemia and Oxidative Stress or Impaired HDL Function', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Influence of Glycaemic Variability on Oxidative Stress and High-density Lipoprotein (HDL) Function in Type-1 Diabetes', 'orgStudyIdInfo': {'id': 'Duvillard Hors AOI 2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patients with type-1 diabetes', 'interventionNames': ['Biological: blood sample', 'Biological: urine sample', 'Device: installation of Holter']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Controls', 'interventionNames': ['Biological: blood sample', 'Biological: urine sample']}], 'interventions': [{'name': 'blood sample', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Controls', 'patients with type-1 diabetes']}, {'name': 'urine sample', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Controls', 'patients with type-1 diabetes']}, {'name': 'installation of Holter', 'type': 'DEVICE', 'armGroupLabels': ['patients with type-1 diabetes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'CHU Dijon Bourgogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}