NCT04950634Completed
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
Source: ClinicalTrials.gov · Last updated 7 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 320 (actual)
- First submitted
- 30 May 2021
- Start date
- 1 Sept 2018
- Primary completion date
- 1 Aug 2025
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Diseases
- Type 1 diabetes
- NCT number
- NCT04950634
What you commit to
- Study type: Observational
- Participants enrolled: 320
- From 1 Sept 2018 to the primary completion date, 1 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Renal transplantation or renal replacement therapy;
- prior diagnosis of macrovascular disease (CHD, cerebrovascular disease, carotid disease, PAD, or atherosclerotic aortic aneurism);
Other illness
- diagnosis of types of diabetes mellitus other than type 1;
Other
- ongoing pregnancy;
- diagnosis of types of neuropathy other than diabetic neuropathy.
Who the study is looking for
- \- Diagnosis of type 1 diabetes mellitus, as defined by ADA criteria
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lía Nattero-Chávez Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.