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 range18 Years – 45 Years

SexFEMALE

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.

What they're measuring

Prevalence of PCOS in T1DM

Timeframe: 2020-2022

Prevalence of classic PCOS in T1DM

Timeframe: 2020-2022

Prevalence of hyperandrogenic PCOS in T1DM

Timeframe: 2020-2022

Trial details

NCT IDNCT04979377

SponsorFundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-12-30

View on ClinicalTrials.gov More Type 1 Diabetes trials