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Polycystic Ovary Syndrome in Type 1 Diabetes
Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Summary
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.
Official title: Pathogenesis of Functional Hyperandrogenism in Women With Type 1 Diabetes Mellitus: From Genetic-molecular Mechanisms to Clinical Phenotype.
Key Details
Gender
All
Age Range
18 Years - 45 Years
Study Type
OBSERVATIONAL
Enrollment
60
Start Date
2026-04-01
Completion Date
2028-12-31
Last Updated
2026-03-24
Healthy Volunteers
Yes
Interventions
Type 1 diabetes mellitus
A diagnosis of type 1a diabetes mellitus
Elevated circulating androgen levels
Androgen excess exposition due to a diagnosis of polycystic syndrome or male sex
Sex dimorphism
Effects of sex on outcomes measures
Locations (1)
Department of Endocrinology and Clinical Nutrition, Hospital Universitario Ramón y Cajal, Carretera de Colmenar Viejo, Km 9.1, 28034-Madrid (Spain)
Madrid, Madrid, Spain