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NCT04979377
Prevalence of Hyperandrogenism in Type 1 Diabetes
trial testing Clinical hyperandrogenism assessment in Type 1 Diabetes in 150 participants. Completed in 30 December 2024.
30 December 2024
Quick facts
| Lead sponsor | Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 150 |
| Start date | 9 March 2020 |
| Primary completion | 30 December 2024 |
| Estimated completion | 30 December 2024 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Clinical hyperandrogenism assessment
- Total testosterone (ng/dL)
- A1c (%)
- Total cholesterol
- Body mass index (BMI) (kg/m2)
- Frequency of chronic vascular complications [n (%)]
- Polycystic ovary morphology
- Cardiovascular autonomic reflex tests (CARTs)
- Sex hormone-binding globulin (SHBG) (nmol/L)
- Dehydroepiandrosterone-sulphate (IQL) (ng/mL)
- Waist circumference (cm)
- Waist-to-hip ratio
- Body composition
- Mean glucose (mg/dL)
- Time in target range (hours)
- Time in hyperglycemia (hours)
- Insulin dose (UI/Kg)
- Insulin sensitivity
- High-density lipoprotein (HDL) (mg/dL)
- Low-density lipoprotein (LDL) (mg/dL)
- Triglycerides (mg/dL)
Conditions studied
- Type 1 Diabetes — all drugs for Type 1 Diabetes →
- Polycystic Ovary Syndrome — all drugs for Polycystic Ovary Syndrome →
- Hyperandrogenism — all drugs for Hyperandrogenism →
- Hirsutism — all drugs for Hirsutism →
Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Who can join
Adults 18 to 45, female only, with Type 1 Diabetes or Polycystic Ovary Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The investigators aim to estimate the prevalence of functional ovarian hyperandrogenism \[idiopathic hyperandrogenism, idiopatic hirsutism, and polycystic ovary syndrome (PCOS)\] in adult patients with type 1 diabetes (T1DM) in an observational cross-sectional study. Study population is comprised of premenopausal adult women with a diagnosis of T1DM, consecutively recruited from a Diabetes outpatient clinic at a tertiary hospital in Spain, Europe.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04979377
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal trials
Trials by the same sponsor.
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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 NCT04979377 (US National Library of Medicine, public domain)
- 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: 17 March 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/NCT04979377.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing