NCT04979377Completed
Prevalence of Hyperandrogenism in Type 1 Diabetes
Prevalence of Hyperandrogenism in Young Women With Type 1 Diabetes and Study of the Underlying Pathophysiological Mechanisms
Source: ClinicalTrials.gov · Last updated 17 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 150 (actual)
- First submitted
- 7 Jul 2021
- Start date
- 9 Mar 2020
- Primary completion date
- 30 Dec 2024
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Diseases
- Type 1 diabetes
- NCT number
- NCT04979377
What you commit to
- Study type: Observational
- Participants enrolled: 150
- From 9 Mar 2020 to the primary completion date, 30 Dec 2024
- 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
- Oral contraceptive or glucocorticoid therapy in the previous 3 months.
Other illness
- Severe chronic disease.
Other
- Honey moon period.
- Altered thyroid hormone or prolactin levels.
- Congenital adrenal hyperplasia.
Who the study is looking for
- Age between 18 and 45 years old
- Type 1 diabetes diagnosed at least 1 year before the inclusion in the study. Diagnosis confirmed by positive autoimmunity (GAD-65 or IA2) and insulin deficiency.
- Treatment with subcutaneus insulin therapy (multiple dose or continuous subcutaneous insulin infusion).
- Menarche at least 2 years before the study.
Age in the registry: 18 years to 45 years · Sex: Female · 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 |
|---|---|---|---|
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.