Prevalence of Hyperandrogenism in Type 1 Diabetes

Summary

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

• Type 1 Diabetes
• Polycystic Ovary Syndrome
• Hyperandrogenism
• Hirsutism
• Oligomenorrhea
• Ovulation Disorder

Interventions

OTHER

Clinical hyperandrogenism assessment

Modified Ferriman-Gallwey scale

DIAGNOSTIC_TEST

Total testosterone (ng/dL)

Circulating total testosterone (LC-MS/MS or IQL-CDC method) at follicular phase

DIAGNOSTIC_TEST

A1c (%)

High Performance Liquid Chromatography (HPLC)

DIAGNOSTIC_TEST

Total cholesterol

Determined by enzymatic methods

OTHER

Body mass index (BMI) (kg/m2)

Defined as body weight divided by the square of body height, and expressed in kg/m2

DIAGNOSTIC_TEST

Frequency of chronic vascular complications [n (%)]

Retinopathy, nephropathy, neuropathy, and macrovascular disease.

DIAGNOSTIC_TEST

Polycystic ovary morphology

Sonographic assessment

DIAGNOSTIC_TEST

Cardiovascular autonomic reflex tests (CARTs)

Cardioautonomic function assessement by Vital scan HW7-HW6T:

DIAGNOSTIC_TEST

Sex hormone-binding globulin (SHBG) (nmol/L)

Circulating SHBG (IQL) at follicular phase

DIAGNOSTIC_TEST

Dehydroepiandrosterone-sulphate (IQL) (ng/mL)

Circulating DHEAS (IQL) at follicular phase

OTHER

Waist circumference (cm)

Waist circumference measurement made at the top of the iliac crest

OTHER

Waist-to-hip ratio

Waist circumference divided by hip circumference (measurement should be taken around the widest portion of the buttocks)

OTHER

Body composition

Vital Scan HW7-HW6T

DIAGNOSTIC_TEST

Mean glucose (mg/dL)

Continuous glucose monitoring (GCM) records

DIAGNOSTIC_TEST

Time in target range (hours)

Continuous glucose monitoring (GCM) records

DIAGNOSTIC_TEST

Time in hyperglycemia (hours)

Continuous glucose monitoring (GCM) records

OTHER

Insulin dose (UI/Kg)

Daily insulin dose divided by body weight

OTHER

Insulin sensitivity

Equation that relies on routine clinical measures: A1c, presence of hypertension, and waist circumference

DIAGNOSTIC_TEST

High-density lipoprotein (HDL) (mg/dL)

Enzymatic methods after precipitation of serum with phosphotungstic acid and Mg2+

DIAGNOSTIC_TEST

Low-density lipoprotein (LDL) (mg/dL)

Estimated by the Friedewald's equation.

DIAGNOSTIC_TEST

Triglycerides (mg/dL)

Determined by enzymatic methods

Sponsors & Collaborators

• Hospital Universitario Ramon y Cajal

  collaborator OTHER

• Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders

  collaborator OTHER

• University of Alcala

  collaborator OTHER

• Instituto de Salud Carlos III

  collaborator OTHER_GOV

• Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

  lead OTHER

Principal Investigators

• Manuel Luque-Ramírez, PhD, MD, MBA · CIBERDEM, Instituto de Salud Carlos III

• Héctor F Escobar-Morreale, PhD, MD · University of Alcalá

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-03-09

Primary Completion

2024-12-30

Completion

2024-12-30

Countries

• Spain

Study Locations