Clinical trial NCT04950634: Sexual Dimorphism in Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes
Official title: Sexual Dimorphism in the Prevalence and Progression of Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: type1diabetes
Keywords: cardioautonomic neuropathy
sexual dimorphism
subclinical atherosclerosis
Lead sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
First posted: 2021-07-06
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants are selected from a consecutive cohort of individuals with T1D, who are regularly attending the outpatient clinic of the Diabetes Unit from Hospital Universitario Ramón y Cajal of Madrid.

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.


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.

Primary outcomes:
measure: To address sexual dimorphism in the prevalence of CAN in patients with T1D.
timeFrame: Two years
measure: To address sexual dimorphism in the prevalence of CAN in patients with T1D.
timeFrame: Two years
measure: To address sexual dimorphism in subclinical atherosclerosis in patients with T1D.
timeFrame: Two years
measure: To assess the role of sex on the progression of cardiovascular dysautonomy in patients with T1D.
timeFrame: Four years
measure: To assess the role of sex on the progression of cardiovascular dysautonomy in patients with T1D.
timeFrame: Four years
measure: To assess the role of sex on the progression of subclinical atherosclerosis in patients with T1D.
timeFrame: Four years
Secondary outcomes:
measure: To identify the influence of sex steroids on the evolution of cardiac autonomic dysfunction.
timeFrame: Four years
measure: To identify the influence of sex steroids on the evolution of cardiac autonomic dysfunction.
timeFrame: Four years
measure: To identify the influence of sex steroids on the evolution of subclinical atherosclerosis
timeFrame: Four years
measure: To identify novel circulating markers of CAN
timeFrame: Four years
measure: To identify novel circulating markers of CAN
timeFrame: Four years
measure: To identify novel circulating markers of subclinical atherosclerosis
timeFrame: Four years
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Lía Nattero Chávez
Study officials:
References:
citation: 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.
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 neuropathy of patients with type 1 diabetes. Cardiovasc Diabetol. 2023 Feb 15;22(1):32. doi: 10.1186/s12933-023-01766-y.