Polycystic Ovary Syndrome in Type 1 Diabetes
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About the trial
BACKGROUND Functional ovarian hyperandrogenism, including the polycystic ovary syndrome (PCOS), is very prevalent in women with type 1 diabetes (T1D). The pathogenic mechanisms of this association remain unclear. HYPOTHESIS Individual factors expose or protect women with T1D to/from the development of androgen excess and PCOS. Such androgen excess in women with T1D may increase their cardiometabolic risk. MAIN OBJECTIVE Unveiling the pathogenic mechanisms behind functional hyperandrogenism in women with T1D from a sex/gender-medicine and sexual dimorphism perspective. MATERIAL AND METHOS We have designed a cross-sectional comparative clinical study, including 5 groups of study subjects with 12 participans per group: i) Women with T1D \& PCOS. ii) Women with T1D without PCOS. iii) Men with T1D and normal gonadal function. iv) Women with PCOS without diabetes mellitus v) Non-hyperandrogenic control women without T1D. All groups will show similar age and body mass index. T1D groups will be matched for duration of disease. OUTCOMES 1.1 Insulin sensitivity (hyperinsulinaemic euglycaemic clamping). 1.2 Body composition (dual-energy x-ray absorptiometry, bioelectrical impedance analysis \& sonographic studies). 1.3 Ovarian and adrenal steroidogenesis. 2.1 Differential pattern in genetic variants related with insulin signalling and response, inflammation, adiposity, gonadal function, steroidogenesis, and PCOS itself by whole exome sequencing. 2.2 Microbiopsy studies in deep subcutaneous adipose tissue and skeletal muscle tissue: 2.2.1 Differential DNA methylation patterns in genes associated with PCOS. 2.2.2 Differential transcriptomic pattern in genes associated with PCOS. 2.2.3 Differential proteomic patterns in adipose and muscle tissues. 3. Interaction between T1D and PCOS on parameters of metabolic control (intersticial blood glucose monitoring) and morbidities associated with T1D itself.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Kobieta w wieku 18-45 lat
- •Cukrzyca typu 1 rozpoznana co najmniej 12 miesięcy przed włączeniem do badania
- •Leczenie insuliną podskórną (wiele wstrzyknięć dziennie lub pompka insulinowa)
- •Dostęp do danych kontroli glikemii z ostatniego miesiąca
- •Pierwsza miesiączka co najmniej 3 lata temu
✗ Disqualifies
- •Okres miodowy cukrzycy typu 1 (początkowy okres z lepszą funkcją trzustki)
- •Ciąża lub karmienie piersią
- •Zaburzenia hormonów tarczycy lub podwyższony prolaktynę
- •Wrodzona hiperplazja nadnerczy lub inne przyczyny nadmiaru androgenów
- •Inne poważne choroby przewlekłe
- •Stosowanie antykoncepcji hormonalnej lub kortykosteroidów w ostatnich 3 miesiącach
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 45 Years
- Last updated (source)
- September 3, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Department of Endocrinology and Clinical Nutrition, Hospital Universitario Ramón y Cajal, Carretera de Colmenar Viejo, Km 9.1, 28034-Madrid (Spain)
Madrid, Spain
Trial contact
Manuel Luque-Ramírez, Principal Investigator, PhD, MD, MBA
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/4/2026.
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