Sexual Dimorphism in Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes - Trial NCT04950634
Access comprehensive clinical trial information for NCT04950634 through Pure Global AI's free database. This phase not specified trial is sponsored by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal and is currently Recruiting. The study focuses on type1diabetes. Target enrollment is 320 participants.
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Study Focus
Observational
Sponsor & Location
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Timeline & Enrollment
N/A
Sep 01, 2018
Dec 01, 2025
Primary Outcome
To address sexual dimorphism in the prevalence of CAN in patients with T1D.,To address sexual dimorphism in the prevalence of CAN in patients with T1D.,To address sexual dimorphism in subclinical atherosclerosis in patients with T1D.,To assess the role of sex on the progression of cardiovascular dysautonomy in patients with T1D.,To assess the role of sex on the progression of cardiovascular dysautonomy in patients with T1D.,To assess the role of sex on the progression of subclinical atherosclerosis in patients with T1D.
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT04950634
Non-Device Trial