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Prevalence of Hyperandrogenism in Type 1 Diabetes 150 Observacional

Concluído
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O estudo clínico NCT04979377 foi um estudo observacional para Diabetes tipo 1, Síndrome do ovário policístico, Hiperandrogenismo, Hirsutismo, Oligomenorreia, Distúrbio de ovulação. Seu status atual é: concluído. O estudo começou em 9 de março de 2020 e incluiu 150 participantes. Coordenado por Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal e foi concluído em 30 de dezembro de 2024. Essas informações foram atualizadas no ClinicalTrials.gov em 17 de março de 2025.
Resumo
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 tert...Mostrar mais
Descrição detalhada
Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age, with an estimated prevalence of 6-15% of the general population worldwide. This heterogeneous syndrome has significant cardio-metabolic, reproductive, and psycho-emotional consequences, and therefore, a prompt recognition and management is of paramount importance for these women. Despite hyperandrogenism is the corner...Mostrar mais
Título oficial

Prevalence of Hyperandrogenism in Young Women With Type 1 Diabetes and Study of the Underlying Pathophysiological Mechanisms

Condições médicas
Diabetes tipo 1Síndrome do ovário policísticoHiperandrogenismoHirsutismoOligomenorreiaDistúrbio de ovulação
Publicações
Artigos científicos e trabalhos de pesquisa publicados sobre este estudo clínico:
Outros IDs do estudo
  • DM1PCOS
Número NCT
NCT04979377
Data de início (real)
2020-03-09
Última atualização postada
2025-03-17
Data de conclusão (estimada)
2024-12-30
Inscrição (estimada)
150
Tipo de estudo
Observacional
Status
Concluído
Palavras-chave
Polycystic ovary syndrome
Hyperandrogenism
Type 1 diabetes
Prevalence
Hirsutism
Ovulatory dysfunction
Testosterone
Insulin
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
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)
Composição corporal
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
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
Prevalence of PCOS in T1DM
Prevalence of PCOS in women with T1DM according to ESHRE-ASRM/Rotterdam criteria
2020-2022
Prevalence of classic PCOS in T1DM
Prevalence of PCOS in women with T1DM according to classic NIH criteria
2020-2022
Prevalence of hyperandrogenic PCOS in T1DM
Prevalence of PCOS in women with T1DM according to AES-PCOS criteria
2020-2022
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
Prevalence of related traits in women with T1D
Prevalence of related hyperandrogenic traits (idiopatic hirsutism, hyperandrogenemia, oligomenorrhea and isolated polycytic ovarian morphology) in women with T1DM
2020-2022
Influence fo the onset of type 1 diabetes on hyperandrogenism
To assess the influence of the timing of diagnosis of type 1 diabetes in the appearance of hyperandrogenism, and also the possible effect of duration of diabetes.
2020-2022
Influence of Insulin Requirements on hyperandrogenism
To describe daily insulin requirements and their influence on functional hyperandrogenism occurrence. We also aim to determine the effect of the chronic metabolic control in PCOS appearance.
2020-2022
Influence of metabolic control on hyperandrogenism
To describe the influence of metabolic control (A1c) on functional hyperandrogenism occurrence. We also aim to determine the effect of the chronic metabolic control in PCOS appearance.
2020-2022
Influence of body composition on hyperandrogenism
To evaluate the influence of risk factors body composition in the occurrence of ovarian hyperandrogenism and PCOS in women with type 1 diabetes.
2020-2022
Influence of hyperandrogenism on insulin requirements
To describe the influence of hyperandrogenism on metabolic control.
2020-2022
Influence of hyperandrogenism on A1c
To describe the influence of hyperandrogenism on metabolic control.
2020-2022
Influence of hyperandrogenism on mean glucose (GCM)
To describe the influence of hyperandrogenism on metabolic control.
2020-2022
Influence of hyperandrogenism on time in range (GCM)
To describe the influence of hyperandrogenism on metabolic control.
2020-2022
Influence of hyperandrogenism on chronic complications
To describe the influence of hyperandrogenism on the frequency of chronic complications related to type 1 diabetes mellitus
2020-2022
Critérios de elegibilidade

Idades elegíveis
Adulto
Idade mínima
18 Years
Sexos elegíveis
Feminino
  • 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.

  • 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.
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal logoFundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Responsável pelo estudo
Manuel Luque Ramírez, Investigador principal, Co-Principal investigator, Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Sem dados de contato.
1 Locais do estudo em 1 países

Madrid

Hospital Universitario Ramón y Cajal, Madrid, Madrid, 28034, Spain