Sexual Dimorphism in Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes

  • End date
    Dec 13, 2025
  • participants needed
  • sponsor
    Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Updated on 13 September 2023


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.

Condition type1diabetes
Clinical Study IdentifierNCT04950634
SponsorFundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Last Modified on13 September 2023


Yes No Not Sure

Inclusion Criteria

Diagnosis of type 1 diabetes mellitus, as defined by ADA criteria

Exclusion Criteria

Renal transplantation or renal replacement therapy
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
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