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NCT04950634
Sexual Dimorphism in Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes
trial in type1diabetes in 320 participants. Completed in 1 August 2025.
1 August 2025
Quick facts
| Lead sponsor | Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 320 |
| Start date | 1 September 2018 |
| Primary completion | 1 August 2025 |
| Estimated completion | 1 August 2025 |
| Sites | 1 location across Spain |
Conditions studied
- type1diabetes — all drugs for type1diabetes →
Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Who can join
18 and older, any sex, with type1diabetes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Sex differences and sex steroids influence on the presentation and severity of cardiovascular autonomic neuropathy of patients with type 1 diabetes.
Nattero-Chávez L, Insenser M, Quintero Tobar A, Fernández-Durán E, et al · · 2023 · cited 12× · PMID 36793089 · DOI 10.1186/s12933-023-01766-y -
Quantification of lipoproteins by proton nuclear magnetic resonance spectroscopy (<sup>1</sup>H-NMRS) improves the prediction of cardiac autonomic dysfunction in patients with type 1 diabetes.
Nattero-Chávez L, Insenser M, Amigó N, Samino S, et al · · 2024 · cited 3× · PMID 38182920 · DOI 10.1007/s40618-023-02289-9 -
Investigating the Link between Intermediate Metabolism, Sexual Dimorphism, and Cardiac Autonomic Dysfunction in Patients with Type 1 Diabetes.
Insenser MR, Nattero-Chávez L, Luque-Ramírez M, Quiñones SL, et al · · 2024 · cited 1× · PMID 39195532 · DOI 10.3390/metabo14080436 -
Point-of-care sural nerve conduction could predict the presence of cardiovascular autonomic neuropathy in type 1 diabetes mellitus.
Nattero-Chávez L, Luque-Ramírez M, Quiñones-Silva J, Montánez L, et al · · 2022 · cited 1× · PMID 35389567 · DOI 10.1111/jdi.13803 -
Unveiling Silent Atherosclerosis in Type 1 Diabetes: The Role of Glycoprotein and Lipoprotein Lipidomics, and Cardiac Autonomic Neuropathy.
de Lope Quiñones S, Luque-Ramírez M, Michael Fernández AC, Quintero Tobar A, et al · · 2025 · PMID 39852397 · DOI 10.3390/metabo15010055
Verify or expand the search:
- PubMed search for NCT04950634
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04950634 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Last refreshed: 7 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04950634.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing