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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04950634

Enrollment

320

Registered

2021-07-06

Start date

2018-09-01

Completion date

2025-08-01

Last updated

2025-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type1diabetes

Keywords

cardioautonomic neuropathy, sexual dimorphism, subclinical atherosclerosis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
To assess the role of sex on the progression of subclinical atherosclerosis in patients with T1D.	Four years	Mean carotid intima-media thickness (mm)
To address sexual dimorphism in the prevalence of CAN in patients with T1D.	Two years	Blood pressure (mmHg) 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	Blood pressure (mmHg) to active standing and Ewing and Clarke tests.

Secondary

Measure	Time frame	Description
To identify the influence of sex steroids on the evolution of cardiac autonomic dysfunction.	Four years	Heart rate responses (bpm) to active standing and Ewing and Clarke tests.
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	Heart rate responses (bpm) to active standing and Ewing and Clarke tests.
To identify novel circulating markers of subclinical atherosclerosis	Four years	Mean carotid intima-media thickness (mm)

Countries

Spain

Outcome results