Clinical Trials in France / NCT07412028
Recruiting
Not applicable
Identification of Women With Severe Insulin Resistant Syndromes of Genetic Origin Among Patients With "Classic" Polycystic Ovary Syndrome (PCOS)
NCT07412028 · tracked via the Priya Life Science France tracker
Condition(s) studied
Polycystic Ovary SyndromeFamilial Partial LipodystrophyLMNA (LaMin Nuclear A) Related Disorders
Investigational drug(s) / intervention(s)
Genetic analysisBiological analysisimaging testStandard intervention
Genetic analysis: Analyses of the insulin resistance and lipodystrophy gene panel revealed pathogenic or highly susceptible variants in control PCOS patients
Biological analysis: Measurement of adipokines
imaging test: DEXA (Dual-Energy X-ray Absorptiometry)
Standard intervention: Standard intervention
Study summary
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).
Eligibility
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
Primary outcome measure(s)
- Measure of Insulinemia rate during an orally induced hyperglycemia — Day 0
Measure of Insulinemia rate in order to compare the association between the profile of insulin secretion (Insulinemia , C-peptide and glycaemia) during an orally induced hyperglycemia and the known diagnosis of lipodystrophy linked to a mutation of the LMNA (FPLD2) gene. - Measure of C-peptide rate during an orally induced hyperglycemia — Day 0
Measure of C-peptide rate in order to compare the association between the profile of insulin secretion (Insulinemia, C-peptide and glycaemia) during an orally induced hyperglycemia and the known diagnosis of lipodystrophy linked to a mutation of the LMNA (FPLD2) gene. - Measure of glycaemia rate during an orally induced hyperglycemia — Day 0
Measure of glycaemia rate in order to compare the association between the profile of insulin secretion (Insulinemia, C-peptide and glycaemia) during an orally induced hyperglycemia and the known diagnosis of lipodystrophy linked to a mutation of the LMNA (FPLD2) gene. - Research of mutation of the LMNA (FPLD2) gene — Day 0
Research of mutation of the LMNA (FPLD2) gene in order to compare the association between the profile of insulin secretion (Insulinemia, C-peptide and glycaemia) during an orally induced hyperglycemia and the known diagnosis of lipodystrophy linked to a mutation of the LMNA (FPLD2) gene.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Service Endocrinologie, Hôpital St Antoine | Paris | France | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07412028 on ClinicalTrials.gov ↗ ← All trials in France