Polycystic Ovary Syndrome, Glucose Profile, Insulin Resistance, Continuous Glucose Monitoring
Conditions
Keywords
polycystic ovary syndrome, phenotype, glucose profile, insulin resistance, continuous glucose monitoring
Brief summary
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.
Interventions
DEVICEsensor
Free-style-libre pro sensor application for 14 days
DEVICEAge reader
Analysis of glycation end products by AGE reader
Sponsors
Centre Hospitalier Universitaire, Amiens
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in range (TIR) | 14 days | Time in range (TIR) variation between 4 groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time in tight range | 14 days | Time in tight range (70-140 mg/dl) variation between 4 groups |
| Time above the range | 14 days | Time above the range variation in 4 groups |
| Average glycaemia | 14 days | — |
| Glycemic variability | 14 days | — |
| Presence of hypoglycaemia | 14 days | Presence of hypoglycaemia |
| HbA1C | 14 days | — |
| Oral glucose tolerance test data | 14 days | — |
| Evaluation of glycation end products by AGE reader | 14 days | — |
| Assessment of insulin resistance | 14 days | — |
Countries
France
Contacts
CONTACTAbdallah Al-Salameh, Pr
Outcome results
None listed