CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 320 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT04950634
NCT04950634N/ACompleted

Sexual Dimorphism in the Prevalence and Progression of Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal·observational·Posted Jul 6, 2021·Updated Aug 7, 2025

In Brief

An observational study for type1diabetes. Completed, enrolled 320 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
Conditionstype1diabetes
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJul 6, 2021
Enrollment StartSep 1, 2018
Primary CompletionAug 1, 2025
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 5.0 years ago