Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-27 @ 11:07 PM
Study NCT ID:
NCT04950634
Status:
COMPLETED
Last Update Posted:
2025-08-07
First Post:
2021-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sexual Dimorphism in Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 320}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-05', 'studyFirstSubmitDate': '2021-05-30', 'studyFirstSubmitQcDate': '2021-06-25', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To address sexual dimorphism in the prevalence of CAN in patients with T1D.', 'timeFrame': 'Two years', 'description': 'Blood pressure (mmHg) to active standing and Ewing and Clarke tests.'}, {'measure': 'To address sexual dimorphism in the prevalence of CAN in patients with T1D.', 'timeFrame': 'Two years', 'description': 'Heart rate responses (bpm) to active standing and Ewing and Clarke tests.'}, {'measure': 'To address sexual dimorphism in subclinical atherosclerosis in patients with T1D.', 'timeFrame': 'Two years', 'description': 'Mean carotid intima-media thickness (mm)'}, {'measure': 'To assess the role of sex on the progression of cardiovascular dysautonomy in patients with T1D.', 'timeFrame': 'Four years', 'description': 'Blood pressure (mmHg) to active standing and Ewing and Clarke tests.'}, {'measure': 'To assess the role of sex on the progression of cardiovascular dysautonomy in patients with T1D.', 'timeFrame': 'Four years', 'description': 'Heart rate responses (bpm) to active standing and Ewing and Clarke tests.'}, {'measure': 'To assess the role of sex on the progression of subclinical atherosclerosis in patients with T1D.', 'timeFrame': 'Four years', 'description': 'Mean carotid intima-media thickness (mm)'}], 'secondaryOutcomes': [{'measure': 'To identify the influence of sex steroids on the evolution of cardiac autonomic dysfunction.', 'timeFrame': 'Four years', 'description': 'Heart rate responses (bpm) to active standing and Ewing and Clarke tests.'}, {'measure': 'To identify the influence of sex steroids on the evolution of cardiac autonomic dysfunction.', 'timeFrame': 'Four years', 'description': 'Blood pressure (mmHg) to active standing and Ewing and Clarke tests.'}, {'measure': 'To identify the influence of sex steroids on the evolution of subclinical atherosclerosis', 'timeFrame': 'Four years', 'description': 'Mean carotid intima-media thickness (mm)'}, {'measure': 'To identify novel circulating markers of CAN', 'timeFrame': 'Four years', 'description': 'Heart rate responses (bpm) to active standing and Ewing and Clarke tests.'}, {'measure': 'To identify novel circulating markers of CAN', 'timeFrame': 'Four years', 'description': 'Blood pressure (mmHg) to active standing and Ewing and Clarke tests.'}, {'measure': 'To identify novel circulating markers of subclinical atherosclerosis', 'timeFrame': 'Four years', 'description': 'Mean carotid intima-media thickness (mm)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cardioautonomic neuropathy', 'sexual dimorphism', 'subclinical atherosclerosis'], 'conditions': ['type1diabetes']}, 'referencesModule': {'references': [{'pmid': '38182920', 'type': 'BACKGROUND', 'citation': 'Nattero-Chavez L, Insenser M, Amigo N, Samino S, Martinez-Micaelo N, Dorado Avendano B, Quintero Tobar A, Escobar-Morreale HF, Luque-Ramirez M. Quantification of lipoproteins by proton nuclear magnetic resonance spectroscopy (1H-NMRS) improves the prediction of cardiac autonomic dysfunction in patients with type 1 diabetes. J Endocrinol Invest. 2024 Aug;47(8):2075-2085. doi: 10.1007/s40618-023-02289-9. Epub 2024 Jan 6.'}, {'pmid': '39195532', 'type': 'BACKGROUND', 'citation': 'Insenser MR, Nattero-Chavez L, Luque-Ramirez M, Quinones SL, Quintero-Tobar A, Samino S, Amigo N, Dorado Avendano B, Fiers T, Escobar-Morreale HF. Investigating the Link between Intermediate Metabolism, Sexual Dimorphism, and Cardiac Autonomic Dysfunction in Patients with Type 1 Diabetes. Metabolites. 2024 Aug 6;14(8):436. doi: 10.3390/metabo14080436.'}, {'pmid': '36793089', 'type': 'BACKGROUND', 'citation': 'Nattero-Chavez L, Insenser M, Quintero Tobar A, Fernandez-Duran E, Dorado Avendano B, Fiers T, Kaufman JM, Luque-Ramirez M, Escobar-Morreale HF. Sex differences and sex steroids influence on the presentation and severity of cardiovascular autonomic neuropathy of patients with type 1 diabetes. Cardiovasc Diabetol. 2023 Feb 15;22(1):32. doi: 10.1186/s12933-023-01766-y.'}, {'pmid': '31530659', 'type': 'BACKGROUND', 'citation': 'Nattero-Chavez L, Alonso Diaz S, Jimenez-Mendiguchia L, Garcia-Cano A, Fernandez-Duran E, Dorado Avendano B, Escobar-Morreale HF, Luque-Ramirez M. Sexual Dimorphism and Sex Steroids Influence Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes. Diabetes Care. 2019 Nov;42(11):e175-e178. doi: 10.2337/dc19-1375. Epub 2019 Sep 17. No abstract available.'}], 'seeAlsoLinks': [{'url': 'https://rdcu.be/c5I1C', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Sex might interact with cardioautonomic neuropathy (CAN) in the development of macrovascular disease in patients with type 1 diabetes (T1D). The regulation of the autonomic system shows sexual dimorphism, and may contribute to the cardiovascular risk overload in women with T1D.\n\nThe aims of this project are:\n\nA.1) Determining the prevalence of CAN and subclinical atherosclerosis in a large cohort of consecutive patients with T1D as a function of sex (cross-sectional study).\n\nA.2.) Addressing the progression of CAN and subclinical atherosclerosis in patients with T1D as a function of sex (longitudinal prospective study).\n\nA.3.) Investigating the influence of sex steroids and circulating biomarkers in the development and progression of CAN and subclinical atherosclerosis.\n\nResearch designs:\n\nA cross-sectional design/prevalence screening study determining the prevalence of CAN as a function of sex in 320 consecutive individuals with DM1.\n\nA longitudinal prospective study: the cohort of prevalence screening study will be prospectively followed, and the assessment of cardiovascular autonomic function and subclinical atherosclerosis will be repeated over time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants are selected from a consecutive cohort of individuals with T1D, who are regularly attending the outpatient clinic of the Diabetes Unit from Hospital Universitario Ramón y Cajal of Madrid.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Diagnosis of type 1 diabetes mellitus, as defined by ADA criteria\n\nExclusion Criteria:\n\n* Renal transplantation or renal replacement therapy;\n* prior diagnosis of macrovascular disease (CHD, cerebrovascular disease, carotid disease, PAD, or atherosclerotic aortic aneurism);\n* ongoing pregnancy;\n* diagnosis of types of diabetes mellitus other than type 1;\n* diagnosis of types of neuropathy other than diabetic neuropathy.'}, 'identificationModule': {'nctId': 'NCT04950634', 'briefTitle': 'Sexual Dimorphism in Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal'}, 'officialTitle': 'Sexual Dimorphism in the Prevalence and Progression of Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes', 'orgStudyIdInfo': {'id': '189/17'}}, 'contactsLocationsModule': {'locations': [{'zip': '28034', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Lía Nattero Chávez', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}