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Clinical Trial Summary

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. 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.


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


NCT number NCT04950634
Study type Observational
Source Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Contact Lía Nattero Chávez, MD PhD
Phone +34913369029
Email marialia.nattero@salud.madrid.org
Status Recruiting
Phase
Start date September 1, 2018
Completion date December 2025

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