Identification of Women With Severe Insulin Resistant Syndromes of Genetic Origin Among Patients With "Classic" Polycystic Ovary Syndrome (PCOS)
Recruiting · NCT07412028 · Interventional (participants receive a specific treatment) · Lead sponsor: Assistance Publique - Hôpitaux de Paris
View the official record on ClinicalTrials.gov →Interventions studied
Biological analysisGenetic analysisStandard interventionimaging test
What this trial is about
Diagnostic case-control study (1 case for 2 controls). Inclusion of patients with severe insulin resistance syndrome of genetic origin, then inclusion of controls: patients examined for PCOS in day hospital with matching age (+/- 5 years) and Body mass index (+/- 5kg/m2).
Who can take part
Age range
18 Years to 45 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Women aged ≥ 18 years and \< 45 years ;
- Discontinuation of estrogen-progestin therapyfor at least 3 months ;
- Signed informed consent ;
- Social security affiliation.
- Case (n=25):
- \- Patient with a lipodystrophic syndrome due to a known pathogenic variant of the LMNA gene.
- Control (n=50), :
- \- patient consulting for polycystic ovary syndrome (PCOS according to the Rotterdam criteria) in day hospital matched on age +/-5 years and BMI+/-5 kg/m2.
Exclusion criteria
- \- Severe renal insufficiency (GFR \< 30 ml/min) ;
- Hepato-cellular insufficiency (TP \< 50%) ;
- Taking corticosteroids or antiretrovirals ;
- Menopausal women ;
- Taking estrogen-progestin therapy;
- Diabetic patients on insulin : type 1 diabetes or pancreatectomised patients
- Other known causes of hyperandrogenism (21-hydroxylase block, Cushing's syndrome, ovarian tumor).
- Pregnant woman
- Breastfeeding woman
Where it is running
1 location listed.
- Service Endocrinologie, Hôpital St Antoine - Paris, France