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PCOS study hunts for genetic clues behind severe insulin resistance

NCT ID NCT07412028

Knowledge-focused Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 11, 2026 · Updated 4 times

Summary

This study aims to find out whether some women diagnosed with polycystic ovary syndrome (PCOS) actually have a rare genetic condition causing severe insulin resistance. Researchers will compare 25 women with a known LMNA gene mutation (linked to lipodystrophy) to 50 women with classic PCOS. They will measure insulin, blood sugar, and other markers during a sugar challenge test, and look for genetic variants. The goal is to improve diagnosis, not to test a new treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors better identify which PCOS patients have an underlying genetic condition, leading to more personalized care.
What could go wrong
This is a small, early-stage diagnostic study, not a treatment trial. It may not change how PCOS is managed in the short term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 81 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

familial partial lipodystrophy familial partial lipodystrophy, Dunnigan type laminopathy polycystic ovary syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Familial partial lipodystrophy Lmna (lamin nuclear A) related disorders Polycystic ovary syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Service Endocrinologie, Hôpital St Antoine

    RECRUITING

    Paris, 75012, France

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