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

Study Overview
=================
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.

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

Conditions
-----------------
type1diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardioautonomic neuropathy, sexual dimorphism, subclinical atherosclerosis