Examining how sex affects heart nerve damage in type 1 diabetes
Sexual Dimorphism in the Prevalence and Progression of Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes
This study looks at how being male or female affects heart nerve damage in people with type 1 diabetes to see if there are differences in heart health over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 320 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal Academic / other |
| Locations | 1 site (Madrid) |
| Trial ID | NCT04950634 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between sexual dimorphism and cardiovascular autonomic neuropathy (CAN) in patients with type 1 diabetes. It aims to determine the prevalence of CAN and subclinical atherosclerosis in a large cohort of individuals, analyzing how these conditions progress over time based on sex. The study will also explore the influence of sex hormones and biomarkers on the development of these cardiovascular issues. The research includes both cross-sectional and longitudinal components to provide a comprehensive understanding of the impact of sex on cardiovascular health in this population.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with type 1 diabetes mellitus.
Not a fit: Patients with prior macrovascular disease or other types of diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of cardiovascular risks in women with type 1 diabetes.
How similar studies have performed: While studies on cardiovascular health in diabetes exist, this specific focus on sexual dimorphism in CAN is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Madrid
- Lía Nattero Chávez — Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Lía Nattero Chávez, MD PhD
- Email: marialia.nattero@salud.madrid.org
- Phone: +34913369029
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.