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

type1diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04950634
• Other study ID #: 189/17
• Status: Recruiting
• Start date: September 1, 2018
• Est. completion date: December 2025

Study information

• Verified date: September 2023
• Source: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Contact: Lía Nattero Chávez, MD PhD
• Phone: +34913369029
• Email: marialia.nattero[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• type1diabetes

Locations

Country	Name	City	State
Spain	Lía Nattero Chávez	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Nattero-Chavez L, Alonso Diaz S, Jimenez-Mendiguchia L, Garcia-Cano A, Fernandez-Duran E, Dorado Avendano B, Escobar-Morreale HF, Luque-Ramirez M. Sexual Dimorphism and Sex Steroids Influence Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes. Diabetes Care. 2019 Nov;42(11):e175-e178. doi: 10.2337/dc19-1375. Epub 2019 Sep 17. No abstract available. — View Citation

Nattero-Chavez L, Insenser M, Quintero Tobar A, Fernandez-Duran E, Dorado Avendano B, Fiers T, Kaufman JM, Luque-Ramirez M, Escobar-Morreale HF. Sex differences and sex steroids influence on the presentation and severity of cardiovascular autonomic neurop — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	To address sexual dimorphism in subclinical atherosclerosis in patients with T1D.	Mean carotid intima-media thickness (mm)	Two years
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	To identify the influence of sex steroids on the evolution of subclinical atherosclerosis	Mean carotid intima-media thickness (mm)	Four years
Secondary	To identify novel circulating markers of CAN	Heart rate responses (bpm) to active standing and Ewing and Clarke tests.	Four years
Secondary	To identify novel circulating markers of CAN	Blood pressure (mmHg) to active standing and Ewing and Clarke tests.	Four years
Secondary	To identify novel circulating markers of subclinical atherosclerosis	Mean carotid intima-media thickness (mm)	Four years

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