IDMet (RaDiCo Cohort) (RaDiCo-IDMet) (IDMet)

February 10, 2026 updated by: Institut National de la Santé Et de la Recherche Médicale, France

National Cohort on Imprinting Disorders and Their Metabolic Consequences

The goal of this observational study is to describe the natural history of imprinting disorders (IDs) according to their metabolic profile in all patients (adults and children) affected with an ID regardless of the severity of the disease, with a molecular characterization, with a signed informed consent for all subjects, followed in one partner's center.

The main questions it aims to answer are:

  • Can we identify common metabolic profiles for all imprinted diseases?
  • Which imprinting disorders have an impact on the metabolic profiles of IDs?
  • Which are the metabolic risks associated to IDs?
  • Can we use the metabolic profiles for the clinical classification and prognosis of IDs?
  • Are there common therapeutic approaches for all IDs?

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Angers, France
        • Not yet recruiting
        • CHU d'Angers
        • Contact:
          • Patrice RODIEN
      • Besançon, France
        • Not yet recruiting
        • Hopital Jean Minjoz
        • Contact:
          • Brigitte MIGNOT
      • Clermont-Ferrand, France
        • Not yet recruiting
        • Hôpital Gabriel Montpied
        • Contact:
          • Igor TAUVERON
      • Le Kremlin-Bicêtre, France
        • Recruiting
        • Hôpital Bicêtre
        • Contact:
          • Agnès LINGLART
      • Lille, France
        • Not yet recruiting
        • Hôpital Jeanne de Flandre
        • Contact:
          • Maryse CARTIGNY
      • Limoges, France
        • Not yet recruiting
        • Hôpital de la mère et de l'enfant
        • Contact:
          • Anne LIENHARDT ROUSSIE
      • Lyon, France
        • Not yet recruiting
        • Hôpital Femme Mère Enfant
        • Contact:
          • Marc NICOLINO
      • Marseille, France
        • Recruiting
        • Hopital de la Timone
        • Contact:
          • Tiffany BUSA
      • Nancy, France
        • Not yet recruiting
        • Hôpital Brabois
        • Contact:
          • Bruno LEHEUP
      • Nantes, France
        • Not yet recruiting
        • Hôpital enfant-adolescent
        • Contact:
          • Sabine BARON
      • Paris, France
        • Recruiting
        • Hopital Necker Enfants Malades
        • Contact:
          • Graziella PINTO
      • Paris, France
        • Not yet recruiting
        • Hôpital Robert Debré
        • Contact:
          • Nicolas DE ROUX
      • Paris, France
        • Recruiting
        • Hôpital de la Pitié-Salpêtrière
        • Contact:
          • Christine POITOU-BERNERT
      • Paris, France
        • Recruiting
        • Hôpital Armand-Trousseau
        • Contact:
          • Irène NETCHINE
      • Rennes, France
        • Recruiting
        • Hopital Sud
        • Contact:
          • Sylvie ODENT
      • Strasbourg, France
        • Not yet recruiting
        • Hôpital Civil
        • Contact:
          • Nathalie GAUTHIER-JEANDIDIER
      • Toulouse, France
        • Recruiting
        • Hopital des Enfants
        • Contact:
          • Maithé TAUBER
      • Toulouse, France
        • Not yet recruiting
        • Hopital des Enfants
        • Contact:
          • Jean-Pierre SALLES
      • Tours, France
        • Not yet recruiting
        • Hopital Bretonneau
        • Contact:
          • Peggy PIERRE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients (adults and children) affected with an ID regardless of the severity of the disease, with a molecular characterization, with a signed informed consent for all subjects, followed in one partner's center.

Description

Inclusion Criteria:

  • Patients (adults and children) affected with an ID regardless of the severity of the disease
  • A confirmed diagnosis of ID (based on molecular diagnosis)
  • A signed informed consent for adults or signed informed consent of parents/guardians of minors/ protected adult.

Non-Inclusion Criteria:

There are no non-inclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The clinical characteristics of IDs in pediatric and adult's patients.
Time Frame: Through study completion, an average of 10 years
Through study completion, an average of 10 years
The genetic characteristics of IDs in pediatric and adult's patients.
Time Frame: Through study completion, an average of 10 years
Through study completion, an average of 10 years
The biological characteristics of IDs in pediatric and adult's patients.
Time Frame: Through study completion, an average of 10 years
Through study completion, an average of 10 years
The morphometric characteristics of IDs in pediatric and adult's patients.
Time Frame: Through study completion, an average of 10 years
Through study completion, an average of 10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Search for an association between the metabolic phenotype of IDs patients' and their biological profil.
Time Frame: At the time of diagnosis (or at first measurement)
At the time of diagnosis (or at first measurement)
Determination of the prevalence of metabolic abnormalities (MA).
Time Frame: At inclusion
At inclusion
Estimation of the risk for metabolic complications such as obesity, diabetes, cardiovascular disease (CVD), metabolic syndrome.
Time Frame: 10 years after
10 years after
Description of different therapeutic approaches and identification of a common base for all IDs.
Time Frame: Through study completion, an average of 10 years
Through study completion, an average of 10 years
Variations of quality-of-life scores.
Time Frame: Through study completion, an average of 10 years
Through study completion, an average of 10 years
Analyse of (epi)genetic mutations transmission in proband and relatives.
Time Frame: Through study completion, an average of 10 years
Through study completion, an average of 10 years

Other Outcome Measures

Outcome Measure
Time Frame
Identification of different metabolic profile which allow a clinical classification of IDs.
Time Frame: Through study completion, an average of 10 years
Through study completion, an average of 10 years
Description and identification of the most relevant biological and clinical practices for diagnostic and follow-up of ID patients.
Time Frame: Through study completion, an average of 10 years
Through study completion, an average of 10 years
Identification of a group of French patients with the same characteristics.
Time Frame: At inclusion
At inclusion
Search of an association between blood metabolic markers, genetic pattern and gut microbiota.
Time Frame: Through study completion, an average of 10 years
Through study completion, an average of 10 years
Description of different scientific rational for transferring a therapeutic approach (clinical guidelines) from an ID to another (identification of common phenotype, i.e. metabolic profile).
Time Frame: Through study completion, an average of 10 years
Through study completion, an average of 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Principal Investigator: Agnès LINGLART, Inserm U1169

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2017

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

June 26, 2023

First Submitted That Met QC Criteria

July 6, 2023

First Posted (Actual)

July 14, 2023

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C15-63

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prader-Willi Syndrome

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe