Polycystic Ovary Syndrome in Type 1 Diabetes

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.

Conditions

• Type 1 Diabetes Mellitus
• Polycystic Ovary Syndrome (PCOS)

Interventions

OTHER

Type 1 diabetes mellitus

A diagnosis of type 1a diabetes mellitus

OTHER

Elevated circulating androgen levels

Androgen excess exposition due to a diagnosis of polycystic syndrome or male sex

OTHER

Sex dimorphism

Effects of sex on outcomes measures

Sponsors & Collaborators

• Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders

  collaborator OTHER

• University of Alcala

  collaborator OTHER

• Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

  lead OTHER

Principal Investigators

• Manuel Luque-Ramírez, PhD, MD, MBA · Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS) & CIBERDEM & Universidad de Alcalá de Henares

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-04-01

Primary Completion

2028-06-30

Completion

2028-12-31

Countries

• Spain

Study Locations