RecruitingNot Applicable

Identification of Women With Severe Insulin Resistant Syndromes of Genetic Origin Among Patients With "Classic" Polycystic Ovary Syndrome (PCOS)

France81 participantsStarted 2026-07-21

Plain-language 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).

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Measure of Insulinemia rate during an orally induced hyperglycemia

Timeframe: Day 0

Measure of C-peptide rate during an orally induced hyperglycemia

Timeframe: Day 0

Measure of glycaemia rate during an orally induced hyperglycemia

Timeframe: Day 0

Research of mutation of the LMNA (FPLD2) gene

Timeframe: Day 0

Trial details

NCT IDNCT07412028

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-01

Contact for this trial

Sophie LAMOTHE, Doctor

0149282406 sophie.lamothe@aphp.fr

View on ClinicalTrials.gov More Polycystic Ovary Syndrome trials

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Measure of Insulinemia rate during an orally induced hyperglycemia

Timeframe: Day 0

Measure of C-peptide rate during an orally induced hyperglycemia

Timeframe: Day 0

Measure of glycaemia rate during an orally induced hyperglycemia

Timeframe: Day 0

Research of mutation of the LMNA (FPLD2) gene

Timeframe: Day 0