Prevalence of Hyperandrogenism in Type 1 Diabetes (NCT04979377) | Clinical Trial Compass
CompletedNot Applicable
Prevalence of Hyperandrogenism in Type 1 Diabetes
Spain150 participantsStarted 2020-03-09
Plain-language summary
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.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Honey moon period.
* Altered thyroid hormone or prolactin levels.
* Congenital adrenal hyperplasia.
* Severe chronic disease.
* Oral contraceptive or glucocorticoid therapy in the previous 3 months.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Prevalence of PCOS in T1DM
Timeframe: 2020-2022
2
Prevalence of classic PCOS in T1DM
Timeframe: 2020-2022
3
Prevalence of hyperandrogenic PCOS in T1DM
Timeframe: 2020-2022
Trial details
NCT IDNCT04979377
SponsorFundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal