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

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Status: Completed

Conditions: type1diabetes

Study type: Observational

Funder types: Other

Identifiers

NCT04950634

189/17

Details and patient eligibility

About

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.

Enrollment: 320 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.