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

Recruiting

• Conditions: type1diabetes

• Registration Number: NCT04950634
• Lead Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2021-05-30
• Study First Submitted QC: 2021-06-25
• Study First Posted: 2021-07-06
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-01
• Last Update Posted: 2023-09-06
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 320

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To address sexual dimorphism in the prevalence of CAN in patients with T1D.	Two years	Heart rate responses (bpm) to active standing and Ewing and Clarke tests.
To address sexual dimorphism in subclinical atherosclerosis in patients with T1D.	Two years	Mean carotid intima-media thickness (mm)
To assess the role of sex on the progression of cardiovascular dysautonomy in patients with T1D.	Four years	Heart rate responses (bpm) to active standing and Ewing and Clarke tests.
To assess the role of sex on the progression of subclinical atherosclerosis in patients with T1D.	Four years	Mean carotid intima-media thickness (mm)

Secondary Outcome Measures

Name	Time	Method
To identify the influence of sex steroids on the evolution of cardiac autonomic dysfunction.	Four years	Blood pressure (mmHg) to active standing and Ewing and Clarke tests.
To identify novel circulating markers of subclinical atherosclerosis	Four years	Mean carotid intima-media thickness (mm)
To identify the influence of sex steroids on the evolution of subclinical atherosclerosis	Four years	Mean carotid intima-media thickness (mm)
To identify novel circulating markers of CAN	Four years	Blood pressure (mmHg) to active standing and Ewing and Clarke tests.

Trial Locations

Locations (1)

Lía Nattero Chávez; 🇪🇸 Madrid, Spain