Sexual Dimorphism in Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes
NCT ID: NCT04950634
Last Updated: 2025-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
320 participants
OBSERVATIONAL
2018-09-01
2025-08-01
Brief Summary
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The aims of this project are:
A.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).
A.2.) Addressing the progression of CAN and subclinical atherosclerosis in patients with T1D as a function of sex (longitudinal prospective study).
A.3.) Investigating the influence of sex steroids and circulating biomarkers in the development and progression of CAN and subclinical atherosclerosis.
Research designs:
A cross-sectional design/prevalence screening study determining the prevalence of CAN as a function of sex in 320 consecutive individuals with DM1.
A 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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* prior diagnosis of macrovascular disease (CHD, cerebrovascular disease, carotid disease, PAD, or atherosclerotic aortic aneurism);
* ongoing pregnancy;
* diagnosis of types of diabetes mellitus other than type 1;
* diagnosis of types of neuropathy other than diabetic neuropathy.
18 Years
ALL
No
Sponsors
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Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
OTHER
Responsible Party
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Locations
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Lía Nattero Chávez
Madrid, Madrid, Spain
Countries
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References
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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.
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.
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.
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.
Related Links
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Related Info
Other Identifiers
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189/17
Identifier Type: -
Identifier Source: org_study_id
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