Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-28 @ 5:06 AM
Study NCT ID:
NCT04474535
Status:
UNKNOWN
Last Update Posted:
2020-07-17
First Post:
2020-07-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
C-peptide Correlation With Microvascular Complications in T1DM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D048909', 'term': 'Diabetes Complications'}], '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum, plasma, urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-13', 'studyFirstSubmitDate': '2020-07-13', 'studyFirstSubmitQcDate': '2020-07-13', 'lastUpdatePostDateStruct': {'date': '2020-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'C-peptide concentrations', 'timeFrame': '1 day', 'description': 'Concentrations of plasma c-peptide in the fasting condition'}, {'measure': 'Microvascular complications', 'timeFrame': '1 day', 'description': 'Presence of microvascular complications'}, {'measure': 'Macrovascular complications', 'timeFrame': '1 day', 'description': 'Presence of macrovascular complications'}], 'secondaryOutcomes': [{'measure': 'Association between c-peptide and complications', 'timeFrame': '1 day', 'description': 'Positive or negative association between c-peptide concentrations and presence of microvascular or macrovascular diabetes complications'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes', 'C-peptide', 'Diabetes Complications']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the presence of residual insulin secretion in patients with DM1 and its correlation with the possible protection against early microvascular and macrovascular complications, emphasizing on the functionality of the myocardium.', 'detailedDescription': "The study will include approximately 200 patients, male and female, with DM1 who are being followed in the outpatient diabetic clinic of our hospital.\n\nEach patient will visit the Research Laboratory of the Diabetes Centre of our Department. The visit will take place in the morning in a fasting state of about 12 hours. Demographic data will be recorded along with the patients' habits, lifestyle, current medication and complete medical history of concomitant diseases.\n\nThis will be followed by anthropometric measurements (weight, height, BMI) and afterwards blood samples will be taken for the determination of urea, creatinine, glucose, HbA1c and lipids. Part of each blood sample will be collected in tubes containing EDTA to determine fasting c-peptide concentrations. The presence of microalbuminuria will be assessed from a morning urine sample by calculating urinary albumin to creatinine ratio (ACR).\n\nThe functionality of the heart's autonomic nervous system will be assessed through the use of heart rate variability (HRV) measurements, using the standard Ewing's tests panel: deep inhalation, standing up and Valsalva's manoeuvre. Changes in blood pressure when changing from the supine to the standing position will also be recorded. Subsequently, the distensibility of the large vessels will be determined, by calculating the conduction velocity of the pulse wave between the carotid and the femoral artery (pulse wave velocity (PWV)).\n\nFinally, a full transthoracic echocardiographic study will be carried out to assess functionality, systolic and diastolic, of the left ventricle (LV).\n\nAll data will be recorded in an electronic database for statistical processing."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients with type 1 diabetes followed in our Diabetes outpatient clinic', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 diabetes\n* Informed consent form\n\nExclusion Criteria:\n\n* Known macrovascular complications\n* Known serious microvascular complications'}, 'identificationModule': {'nctId': 'NCT04474535', 'briefTitle': 'C-peptide Correlation With Microvascular Complications in T1DM', 'organization': {'class': 'OTHER', 'fullName': 'National and Kapodistrian University of Athens'}, 'officialTitle': 'Association of β-cell Secretory Status With Early Microvascular and Macrovascular Complications in Patients With Type 1 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'T1DM C-peptide'}}, 'contactsLocationsModule': {'locations': [{'zip': '11527', 'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Alexandros Kokkinos, MD, PhD', 'role': 'CONTACT', 'email': 'akokkinos@med.uoa.gr', 'phone': '+302132061248'}], 'facility': 'Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'centralContacts': [{'name': 'Alexandros Kokkinos', 'role': 'CONTACT', 'email': 'rjd@otenet.gr', 'phone': '+302132061248'}], 'overallOfficials': [{'name': 'Alexandros Kokkinos', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Department of Propaedeutic Medicine, University of Athens'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National and Kapodistrian University of Athens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor in Internal Medicine', 'investigatorFullName': 'Alexandros Kokkinos', 'investigatorAffiliation': 'National and Kapodistrian University of Athens'}}}}