150
Participants
Start Date
March 9, 2020
Primary Completion Date
December 30, 2024
Study Completion Date
December 30, 2024
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
Hospital Universitario Ramón y Cajal, Madrid
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