Glucose Profiles in Women With Polycystic Ovary Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCentre Hospitalier Universitaire, Amiens
About this trial
Polycystic ovary syndrome is a very common condition that is associated with metabolic complications. Patients with polycystic ovary syndrome exhibit insulin resistance and are at greater risk to develop type 2 diabetes. This syndrome is heterogeneous, classified according to 4 phenotypes (A-D). It seems that certain phenotypes are less exposed to insulin resistance and metabolic complications. However, only a few studies have evaluated the glucose profile according to phenotype. New technologies now make it possible to monitor glucose levels continuously. The aim of this project is to evaluate glucose profile parameters using continuous glucose monitoring, and to compare these profiles according to different PCOS phenotypes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age > 18 years at inclusion criteria
Patient with polycystic ovary syndrome, defined by the presence of at least 2/3 irregular menstrual cycles, clinical or biological hyperandrogenism, polycystic ovary morphology (pelvic ultrasound) or elevated AMH levels, after the exclusion of other disorders.
Agreed to carry the FSL pro
Signed informed consent
Disqualifiers
Pregnancy, breast-feeding
Differential diagnoses: hyperprolactinemia, dysthyroidism, Cushing's syndrome, congenital adrenal hyperplasia, virilizing tumor (ovarian or adrenal), intake of exogenous androgens
Pre-existing diabetes
Patient treated within 3 months prior to inclusion/data collection with estrogen-progestin contraception, progestin contraception, antidiabetic drugs, inositol, antiandrogen
Trial design
Design model
Parallel
Treatments tested in this trial
sensor
DeviceFree-style-libre pro sensor application for 14 days
Age reader
DeviceAnalysis of glycation end products by AGE reader
Treatment groups
80 Participants
are divided into 4 treatment groupsGroup A: Phenotype AExperimental treatment 2 interventions
Group B: Phenotype BExperimental treatment 2 interventions
Group C: Phenotype CExperimental treatment 2 interventions
Group D: Phenotype DExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Time in range (TIR)
Time in range (TIR) variation between 4 groups
Time frame
14 daysSecondary outcomes
1
Time in tight range
Time in tight range (70-140 mg/dl) variation between 4 groups
Time frame
14 days2
Time above the range
Time above the range variation in 4 groups
Time frame
14 days3
Average glycaemia
Time frame
14 days4
Glycemic variability
Time frame
14 daysSponsors and contacts
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Source ClinicalTrials.gov