Clinical trial · Observational
Prevalence of Hyperandrogenism in Type 1 Diabetes
Prevalence of Hyperandrogenism in Young Women With Type 1 Diabetes and Study of the Underlying Pathophysiological Mechanisms
NCT04979377CI-TRIAL-00087268completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators aim to estimate the prevalence of functional ovarian hyperandrogenism \[idiopathic hyperandrogenism, idiopatic hirsutism, and polycystic ovary syndrome (PCOS)\] in adult patients with type 1 diabetes (T1DM) in an observational cross-sectional study. Study population is comprised of premenopausal adult women with a diagnosis of T1DM, consecutively recruited from a Diabetes outpatient clinic at a tertiary hospital in Spain, Europe.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hirsutism | — | UNRESOLVED | — |
| Hyperandrogenism | — | UNRESOLVED | — |
| Oligomenorrhea | — | UNRESOLVED | — |
| Ovulation Disorder | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
| Type 1 Diabetes | — | UNRESOLVED | — |
Interventions
Interventions (21)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| A1c (%) | Diagnostic Test | — | UNRESOLVED |
| Body composition | Other | — | UNRESOLVED |
| Body mass index (BMI) (kg/m2) | Other | — | UNRESOLVED |
| Cardiovascular autonomic reflex tests (CARTs) | Diagnostic Test | — | UNRESOLVED |
| Clinical hyperandrogenism assessment | Other | — | UNRESOLVED |
| Dehydroepiandrosterone-sulphate (IQL) (ng/mL) | Diagnostic Test | — | UNRESOLVED |
| Frequency of chronic vascular complications [n (%)] | Diagnostic Test | — | UNRESOLVED |
| High-density lipoprotein (HDL) (mg/dL) | Diagnostic Test | — |
Design
Arms and outcomes
Arms (1)
- label
- Adult premenopausal women with type 1 diabetes mellitus
- description
- One-hundred and fifty women aged from 18 to 45 years old consecutively recruited from a type 1 diabetes clinic at a tertiary hospital of Madrid, Spain
- interventionNames
- Other: Clinical hyperandrogenism assessment
- Diagnostic Test: Total testosterone (ng/dL)
- Diagnostic Test: A1c (%)
- Diagnostic Test: Total cholesterol
- Other: Body mass index (BMI) (kg/m2)
- Diagnostic Test: Frequency of chronic vascular complications [n (%)]
- Diagnostic Test: Polycystic ovary morphology
- Diagnostic Test: Cardiovascular autonomic reflex tests (CARTs)
- Diagnostic Test: Sex hormone-binding globulin (SHBG) (nmol/L)
- Diagnostic Test: Dehydroepiandrosterone-sulphate (IQL) (ng/mL)
- Other: Waist circumference (cm)
- Other: Waist-to-hip ratio
- Other: Body composition
- Diagnostic Test: Mean glucose (mg/dL)
- Diagnostic Test: Time in target range (hours)
- Diagnostic Test: Time in hyperglycemia (hours)
- Other: Insulin dose (UI/Kg)
- Other: Insulin sensitivity
- Diagnostic Test: High-density lipoprotein (HDL) (mg/dL)
- Diagnostic Test: Low-density lipoprotein (LDL) (mg/dL)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Age between 18 and 45 years old * Type 1 diabetes diagnosed at least 1 year before the inclusion in the study. Diagnosis confirmed by positive autoimmunity (GAD-65 or IA2) and insulin deficiency. * Treatment with subcutaneus insulin therapy (multiple dose or continuous subcutaneous insulin infusion). * Menarche at least 2 years before the study. Exclusion Criteria: * Honey moon period. * Altered thyroid hormone or prolactin levels. * Congenital adrenal hyperplasia. * Severe chronic disease. * Oral contraceptive or glucocorticoid therapy in the previous 3 months.
References
Publications (12)
- BACKGROUNDEscobar-Morreale HF, Roldan B, Barrio R, Alonso M, Sancho J, de la Calle H, Garcia-Robles R. High prevalence of the polycystic ovary syndrome and hirsutism in women with type 1 diabetes mellitus. J Clin Endocrinol Metab. 2000 Nov;85(11):4182-7. doi: 10.1210/jcem.85.11.6931. PMID 11095451
- BACKGROUNDRoldan B, Escobar-Morreale HF, Barrio R, de La Calle H, Alonso M, Garcia-Robles R, Sancho J. Identification of the source of androgen excess in hyperandrogenic type 1 diabetic patients. Diabetes Care. 2001 Jul;24(7):1297-9. doi: 10.2337/diacare.24.7.1297. No abstract available. PMID 11423519
- BACKGROUNDCodner E, Escobar-Morreale HF. Clinical review: Hyperandrogenism and polycystic ovary syndrome in women with type 1 diabetes mellitus. J Clin Endocrinol Metab. 2007 Apr;92(4):1209-16. doi: 10.1210/jc.2006-2641. Epub 2007 Feb 6. PMID 17284617
- BACKGROUNDEscobar-Morreale HF, Roldan-Martin MB. Type 1 Diabetes and Polycystic Ovary Syndrome: Systematic Review and Meta-analysis. Diabetes Care. 2016 Apr;39(4):639-48. doi: 10.2337/dc15-2577. PMID 27208367
- BACKGROUNDCodner E, Soto N, Lopez P, Trejo L, Avila A, Eyzaguirre FC, Iniguez G, Cassorla F. Diagnostic criteria for polycystic ovary syndrome and ovarian morphology in women with type 1 diabetes mellitus. J Clin Endocrinol Metab. 2006 Jun;91(6):2250-6. doi: 10.1210/jc.2006-0108. Epub 2006 Mar 28. PMID 16569737
- BACKGROUNDCodner E, Iniguez G, Villarroel C, Lopez P, Soto N, Sir-Petermann T, Cassorla F, Rey RA. Hormonal profile in women with polycystic ovarian syndrome with or without type 1 diabetes mellitus. J Clin Endocrinol Metab. 2007 Dec;92(12):4742-6. doi: 10.1210/jc.2007-1252. Epub 2007 Sep 25. PMID 17895317
- BACKGROUNDGaete X, Vivanco M, Eyzaguirre FC, Lopez P, Rhumie HK, Unanue N, Codner E. Menstrual cycle irregularities and their relationship with HbA1c and insulin dose in adolescents with type 1 diabetes mellitus. Fertil Steril. 2010 Oct;94(5):1822-6. doi: 10.1016/j.fertnstert.2009.08.039. Epub 2009 Sep 30.