Home › Trials › NCT07490964
Clinical trial Recruiting at 1 site Observational Ages 18 to 45

Polycystic Ovary Syndrome in Type 1 Diabetes

Official title: Pathogenesis of Functional Hyperandrogenism in Women With Type 1 Diabetes Mellitus: From Genetic-molecular Mechanisms to Clinical Phenotype.

Run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · NCT07490964 · Data updated 2026-11-12

This study tests whether women with type 1 diabetes and PCOS differ from other groups in factors that drive androgen excess and what that means for health.

Quick facts

Study typeObservational
Ages18 Years to 45 Years
SexAll
Enrollment60 (estimated)
SponsorFundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Academic / other
Locations1 site (Madrid, Madrid)
StatusRecruiting
StartedApril 1, 2026
Main results expectedJune 30, 2028
Study endsDecember 31, 2028
Registry record updatedSeptember 3, 2026
Trial IDNCT07490964 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Premenopausal women aged 18–45 with type 1 diabetes, with or without PCOS, and matched comparison groups as described.

Probably not a fit

Individuals outside the defined age range or with conditions listed in the exclusion criteria may not benefit from the study findings.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This cross-sectional study compares five groups of participants with and without type 1 diabetes and with and without PCOS to explore factors associated with functional ovarian hyperandrogenism. The groups are: women with T1D and PCOS, women with T1D without PCOS, men with T1D and normal gonadal function, women with PCOS without diabetes, and non-hyperandrogenic women without T1D; each group targets similar age and body mass index. The study aims to understand pathogenic mechanisms behind hyperandrogenism from sex/gender and sexual dimorphism perspectives, focusing on how endogenous and environmental factors may promote or protect against androgen excess. Data collection will include metabolic control information and clinical assessments to identify associations with cardiometabolic risk. The design is observational and cross-sectional, with careful eligibility criteria to focus on premenopausal adults.

Why it matters

Potential benefit: Findings could clarify how T1D and PCOS interact to influence cardiometabolic risk and guide personalized risk stratification.

How similar studies have gone: Previous research has explored links between diabetes, PCOS, and hyperandrogenism, but this exact multi-group cross-sectional approach in T1D populations is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria 
1. Non--hyperandrogenic women with type 1 diabetes INCLUSION CRITERIA

   * Premenopausal women between 18 and 45 years old.
   * Diagnosis of type 1a diabetes at least 12 months before inclusion in the study, confirmed by positive autoimmunity and complete insulin deficiency.
   * Treatment with subcutaneous insulin therapy (multiple doses or continuous infusion).
   * Availability of metabolic control data (continuous interstitial blood glucose monitoring) at least in the month prior to study entry.
   * Menarche at least three years prior to study entry. EXCLUSION CRITERIA
   * Honeymoon period of T1D.
   * Pregnancy or lactation.
   * Thyroid hormone dysfunction or hyperprolactinaemia.
   * Diagnosis of non-classical congenital adrenal hyperplasia or other secondary causes of hyperandrogenism.
   * Diagnosis of other serious chronic disease.
   * Treatment with oral contraceptives or glucocorticoid therapy in the 3 months prior to inclusion in the study.
2. Women with type 1 diabetes and polycystic ovary syndrome INCLUSION CRITERIA

   * Women between 18 and 45 years old.
   * Diagnosis of type 1a diabetes at least 12 months before inclusion in the study, confirmed by positive autoimmunity and complete insulin deficiency.
   * Treatment with subcutaneous insulin therapy (multiple doses or continuous infusion).
   * Availability of metabolic control data (continuous interstitial blood glucose monitoring) at least in the month prior to study entry.
   * Menarche at least three years prior to study entry.
   * PCOS diagnosis based on the 2012 American NIH consensus criteria, including the Rotterdam and AE-PCOS.

   EXCLUSION CRITERIA
   * Honeymoon period of T1D.
   * Pregnancy/lactation.
   * Thyroid hormone dysfunction or hyperprolactinaemia.
   * Diagnosis of non-classical congenital adrenal hyperplasia or other secondary causes of hyperandrogenism.
   * Diagnosis of other serious chronic disease. reatment with oral contraceptives or glucocorticoid therapy in the 3 months prior to inclusion in the study.
3. Men with T1D and normal gonadal function of similar age, BMI, and duration of diabetes.

   INCLUSION CRITERIA
   * Age between 18 and 45 years old.
   * Diagnosis of type 1a diabetes at least 12 months before inclusion in the study, confirmed by positive autoimmunity and complete insulin deficiency.
   * Treatment with subcutaneous insulin therapy (multiple doses or continuous infusion).
   * Availability of metabolic control data (continuous interstitial blood glucose monitoring) at least in the month prior to study entry.

   EXCLUSION CRITERIA
   * Honeymoon period of T1D.
   * Thyroid hormone dysfunction or hyperprolactinaemia.
   * Diagnosis of non-classical congenital adrenal hyperplasia.
   * Diagnosis of male hypogonadism.
4. Women with PCOS of similar age and BMI. INCLUSION CRITERIA

   * Women between 18 and 45 years old.
   * Menarche at least three years prior to study entry.
   * PCOS diagnosis based on the 2012 American NIH consensus criteria, including the Rotterdam and AE-PCOS.

   EXCLUSION CRITERIA
   * Pregnancy/lactation.
   * Previously known carbohydrate metabolism abnormalities (prediabetes or type 2 diabetes).
   * Thyroid hormone dysfunction or hyperprolactinaemia.
   * Diagnosis of non-classical congenital adrenal hyperplasia or other secondary causes of hyperandrogenism.
   * Diagnosis of other serious chronic disease.
   * Treatment with oral contraceptives or glucocorticoid therapy in the 3 months prior to inclusion in the study.
5. Non-hyperandrogenic control women with regular menses of similar age and BMI. INCLUSION CRITERIA

   * Women between 18 and 45 years old.
   * Menarche at least three years prior to study entry.
   * Presence of regular menses.
   * Lack of signs or symptoms of functional hyperandrogenism. EXCLUSION CRITERIA
   * Pregnancy/lactation.
   * Previously known carbohydrate metabolism disturbances.
   * Thyroid hormone dysfunction or hyperprolactinaemia.
   * Diagnosis of non-classical congenital adrenal hyperplasia or other secondary causes of hyperandrogenism.
   * Diagnosis of other serious chronic disease.
   * Treatment with oral contraceptives or glucocorticoid therapy in the 3 months prior to inclusion in the study.

Where it's running

  • Department of Endocrinology and Clinical Nutrition, Hospital Universitario Ramón y Cajal, Carretera de Colmenar Viejo, Km 9.1, 28034-Madrid (Spain)
    Madrid, Madrid, Spain     Recruiting

Study contacts

  • Principal investigator: Manuel Luque-Ramírez, PhD, MD, MBA — Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS) & CIBERDEM & Universidad de Alcalá de Henares
  • Study coordinator: Manuel Luque-Ramírez, Principal Investigator, PhD, MD, MBA
  • Email: manuel.luque@salud.madrid.org
  • Phone: +34 913368000

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.