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Polycystic Ovary Syndrome in Type 1 Diabetes

Recruitingn/aAges 18 Years - 45 YearsAllFundacion para la Investigacion Biomedica del Hosโ€ฆ
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In plain words

What the trial is, and whether it could suit you

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-hyperandro

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๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Type 1 diabetes mellitus
  • Elevated circulating androgen levels
  • Sex dimorphism
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Where

1 site
Department of Endocrinology and Clinical Nutrition, Hospital Universitario Ramรณn y Cajal, Carretera de Colmenar Viejo, Km 9.1, 28034-Madrid (Spain)
Madrid, Spain
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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