Study Results
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Basic Information
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COMPLETED
150 participants
OBSERVATIONAL
2020-03-09
2024-12-30
Brief Summary
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Detailed Description
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The investigators hypothesize that the prevalence of functional hyperandrogenism including PCOS in Spanish women with T1D is higher than in women from the general population. Furthermore, signs and symptoms of hyperandrogenism, and hyperandrogenemia may be milder in patients with T1D compared to hyperandrogenic women from the general population. Moreover, the occurrence of PCOS in these women may be influenced by insulin dose, duration of diabetes, and chronic metabolic control.
The main objective of this study is to determine the actual prevalence of PCOS in premenopausal women with T1DM, according to different diagnostic criteria/PCOS phenotypes \[classic PCOS (classic NIH criteria), hyperandrogenic PCOS (AES-PCOS criteria), and/or inclusive ESHRE-ASRM/Rotterdam criteria\]. As secondary goals, the investigators also aim to describe: i) the hyperandrogenic traits associated with PCOS in women with T1DM; and ii) the metabolic-T1D related parameters in women with or without hyperandrogenism.
Sample size calculation: Sample size analysis used the online sample size and power calculator from the Program of Research in Inflammatory and Cardiovascular Disorders, Institut Municipal d'Investigació Mèdica, Barcelona, Spain (https://www.imim.cat/ofertadeserveis/software-public/granmo/). Considering previous data on prevalence of SOP in adolescents and adult women with T1D according to ESHRE-ASRM/Rotterdam criteria, the investigators concluded that 150 participants would be needed to assume an expected proportion of 40%, with an absolute precision of 5% at both sides of the proportion, and an asymptotic bilateral 95% confidence interval, and with an estimated replacement rate of 10%.
Statistical analysis: Continuous variables will be expressed as mean ± SD with its respective 95% confidence intervals (95%CI). Normality of continuous variables will be checked by the Kolmogorov-Smirnov test, and ensured by applying logarithmic transformations. the investigators will use non-parametric tests to analyse variables that remained skewed even after transformation. The differences in means will be analysed by Student t or Mann-Whitney U tests. Discrete variables will be showed according to their absolute, relative frequency, and 95%CI determined using the Wilson method without continuity correction. The differences between proportions will be estimated using the χ2 or Fisher's exact tests. Correlation analysis will be used to evaluate putative association between continuous variables. Finally, multiple linear an binary logistic regression full and stepwise models (probability for entry ≤0.05, probability for removal ≥0.10) will be performed to ascertain the main determinants of predetermined outcomes. The statistical significance will be set at the P \< 0.05 level.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Adult premenopausal women with type 1 diabetes mellitus
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
Clinical hyperandrogenism assessment
Modified Ferriman-Gallwey scale
Total testosterone (ng/dL)
Circulating total testosterone (LC-MS/MS or IQL-CDC method) at follicular phase
A1c (%)
High Performance Liquid Chromatography (HPLC)
Total cholesterol
Determined by enzymatic methods
Body mass index (BMI) (kg/m2)
Defined as body weight divided by the square of body height, and expressed in kg/m2
Frequency of chronic vascular complications [n (%)]
Retinopathy, nephropathy, neuropathy, and macrovascular disease.
Polycystic ovary morphology
Sonographic assessment
Cardiovascular autonomic reflex tests (CARTs)
Cardioautonomic function assessement by Vital scan HW7-HW6T:
Sex hormone-binding globulin (SHBG) (nmol/L)
Circulating SHBG (IQL) at follicular phase
Dehydroepiandrosterone-sulphate (IQL) (ng/mL)
Circulating DHEAS (IQL) at follicular phase
Waist circumference (cm)
Waist circumference measurement made at the top of the iliac crest
Waist-to-hip ratio
Waist circumference divided by hip circumference (measurement should be taken around the widest portion of the buttocks)
Body composition
Vital Scan HW7-HW6T
Mean glucose (mg/dL)
Continuous glucose monitoring (GCM) records
Time in target range (hours)
Continuous glucose monitoring (GCM) records
Time in hyperglycemia (hours)
Continuous glucose monitoring (GCM) records
Insulin dose (UI/Kg)
Daily insulin dose divided by body weight
Insulin sensitivity
Equation that relies on routine clinical measures: A1c, presence of hypertension, and waist circumference
High-density lipoprotein (HDL) (mg/dL)
Enzymatic methods after precipitation of serum with phosphotungstic acid and Mg2+
Low-density lipoprotein (LDL) (mg/dL)
Estimated by the Friedewald's equation.
Triglycerides (mg/dL)
Determined by enzymatic methods
Interventions
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Clinical hyperandrogenism assessment
Modified Ferriman-Gallwey scale
Total testosterone (ng/dL)
Circulating total testosterone (LC-MS/MS or IQL-CDC method) at follicular phase
A1c (%)
High Performance Liquid Chromatography (HPLC)
Total cholesterol
Determined by enzymatic methods
Body mass index (BMI) (kg/m2)
Defined as body weight divided by the square of body height, and expressed in kg/m2
Frequency of chronic vascular complications [n (%)]
Retinopathy, nephropathy, neuropathy, and macrovascular disease.
Polycystic ovary morphology
Sonographic assessment
Cardiovascular autonomic reflex tests (CARTs)
Cardioautonomic function assessement by Vital scan HW7-HW6T:
Sex hormone-binding globulin (SHBG) (nmol/L)
Circulating SHBG (IQL) at follicular phase
Dehydroepiandrosterone-sulphate (IQL) (ng/mL)
Circulating DHEAS (IQL) at follicular phase
Waist circumference (cm)
Waist circumference measurement made at the top of the iliac crest
Waist-to-hip ratio
Waist circumference divided by hip circumference (measurement should be taken around the widest portion of the buttocks)
Body composition
Vital Scan HW7-HW6T
Mean glucose (mg/dL)
Continuous glucose monitoring (GCM) records
Time in target range (hours)
Continuous glucose monitoring (GCM) records
Time in hyperglycemia (hours)
Continuous glucose monitoring (GCM) records
Insulin dose (UI/Kg)
Daily insulin dose divided by body weight
Insulin sensitivity
Equation that relies on routine clinical measures: A1c, presence of hypertension, and waist circumference
High-density lipoprotein (HDL) (mg/dL)
Enzymatic methods after precipitation of serum with phosphotungstic acid and Mg2+
Low-density lipoprotein (LDL) (mg/dL)
Estimated by the Friedewald's equation.
Triglycerides (mg/dL)
Determined by enzymatic methods
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Altered thyroid hormone or prolactin levels.
* Congenital adrenal hyperplasia.
* Severe chronic disease.
* Oral contraceptive or glucocorticoid therapy in the previous 3 months.
18 Years
45 Years
FEMALE
No
Sponsors
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Hospital Universitario Ramon y Cajal
OTHER
Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders
OTHER
University of Alcala
OTHER
Instituto de Salud Carlos III
OTHER_GOV
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
OTHER
Responsible Party
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Manuel Luque Ramírez
Co-Principal investigator
Principal Investigators
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Manuel Luque-Ramírez, PhD, MD, MBA
Role: STUDY_DIRECTOR
CIBERDEM, Instituto de Salud Carlos III
Héctor F Escobar-Morreale, PhD, MD
Role: STUDY_CHAIR
University of Alcalá
Locations
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Hospital Universitario Ramón y Cajal
Madrid, Madrid, Spain
Countries
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References
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Escobar-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.
Roldan 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.
Codner 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.
Escobar-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.
Codner 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.
Codner 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.
Gaete 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.
Codner E, Merino PM, Tena-Sempere M. Female reproduction and type 1 diabetes: from mechanisms to clinical findings. Hum Reprod Update. 2012 Sep-Oct;18(5):568-85. doi: 10.1093/humupd/dms024. Epub 2012 Jun 17.
Nattero-Chavez L, Alonso Diaz S, Jimenez-Mendiguchia L, Garcia-Cano A, Fernandez-Duran E, Dorado Avendano B, Escobar-Morreale HF, Luque-Ramirez M. Sexual Dimorphism and Sex Steroids Influence Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes. Diabetes Care. 2019 Nov;42(11):e175-e178. doi: 10.2337/dc19-1375. Epub 2019 Sep 17. No abstract available.
Teede HJ, Misso ML, Costello MF, Dokras A, Laven J, Moran L, Piltonen T, Norman RJ; International PCOS Network. Recommendations from the international evidence-based guideline for the assessment and management of polycystic ovary syndrome. Hum Reprod. 2018 Sep 1;33(9):1602-1618. doi: 10.1093/humrep/dey256.
Escobar-Morreale HF, Carmina E, Dewailly D, Gambineri A, Kelestimur F, Moghetti P, Pugeat M, Qiao J, Wijeyaratne CN, Witchel SF, Norman RJ. Epidemiology, diagnosis and management of hirsutism: a consensus statement by the Androgen Excess and Polycystic Ovary Syndrome Society. Hum Reprod Update. 2012 Mar-Apr;18(2):146-70. doi: 10.1093/humupd/dmr042. Epub 2011 Nov 6.
Escobar-Morreale HF, Bayona A, Nattero-Chavez L, Luque-Ramirez M. Type 1 diabetes mellitus and polycystic ovary syndrome. Nat Rev Endocrinol. 2021 Dec;17(12):701-702. doi: 10.1038/s41574-021-00576-0. No abstract available.
Other Identifiers
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DM1PCOS
Identifier Type: -
Identifier Source: org_study_id
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