CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 150 enrolled
Drug / intervention
Clinical hyperandrogenism assessment +20 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04979377
NCT04979377N/ACompleted
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Prevalence of Hyperandrogenism in Young Women With Type 1 Diabetes and Study of the Underlying Pathophysiological Mechanisms

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal·observational·Posted Jul 28, 2021·Updated Mar 17, 2025

In Brief

An observational study evaluating Clinical hyperandrogenism assessment, Total testosterone (ng/dL), and 19 other interventions for Type 1 Diabetes and 5 related conditions. Completed, enrolled 150 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes, Polycystic Ovary Syndrome, Hyperandrogenism, Hirsutism, Oligomenorrhea, Ovulation Disorder
CountriesSpain
CollaboratorsHospital Universitario Ramon y Cajal, Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders, University of Alcala, Instituto de Salud Carlos III

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJul 28, 2021
Enrollment StartMar 9, 2020
Primary CompletionDec 30, 2024
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 4.9 years ago

Interventions

Clinical hyperandrogenism assessmentother

Modified Ferriman-Gallwey scale

Total testosterone (ng/dL)other

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

A1c (%)other

High Performance Liquid Chromatography (HPLC)

Total cholesterolother

Determined by enzymatic methods

Body mass index (BMI) (kg/m2)other

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

Frequency of chronic vascular complications [n (%)]other

Retinopathy, nephropathy, neuropathy, and macrovascular disease.

Polycystic ovary morphologyother

Sonographic assessment

Cardiovascular autonomic reflex tests (CARTs)other

Cardioautonomic function assessement by Vital scan HW7-HW6T:

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

Circulating SHBG (IQL) at follicular phase

Dehydroepiandrosterone-sulphate (IQL) (ng/mL)other

Circulating DHEAS (IQL) at follicular phase

Waist circumference (cm)other

Waist circumference measurement made at the top of the iliac crest

Waist-to-hip ratioother

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

Body compositionother

Vital Scan HW7-HW6T

Mean glucose (mg/dL)other

Continuous glucose monitoring (GCM) records

Time in target range (hours)other

Continuous glucose monitoring (GCM) records

Time in hyperglycemia (hours)other

Continuous glucose monitoring (GCM) records

Insulin dose (UI/Kg)other

Daily insulin dose divided by body weight

Insulin sensitivityother

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

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

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

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

Estimated by the Friedewald's equation.

Triglycerides (mg/dL)other

Determined by enzymatic methods