Registry for Patients With Lipodystrophy

NCT03553420 | Recruiting

• 1 other identifier: ECLip Registry
• Study Type: observational
• Target: 5,000
• Locations: 16 countries
• Sites: 28

Brief Summary

Given the lack of knowledge on lipodystrophies, the medical and social responsibility for the persons affected by it calls for the monitoring of the progression over long periods of time. Sensible clinical and basic research into rare diseases such as lipodystrophy is only possible in multi-location networks with sufficient case numbers. Also, reliable information on the incidence of certain manifestation patterns, health status, etc. is of utmost importance for health care and health policy in this rare disease. Therefore, the European Consortium of Lipodystrophies (ECLip), an association of European experts on lipodystrophy, has launched a registry (OSSE) for lipodystrophies which is committed to help to improve the research conditions by consolidating this kind of information in a registry.

Conditions

Lipodystrophy Acquired; Lipodystrophy Congenital

Keywords

lipodystrophy

Outcome Measures

Primary Outcomes (1)

• Age at death

  patients are followed regularly, age at death (years) will be documented

  after 20 years

Secondary Outcomes (5)

• change in somatic comorbidities under standard treatment

  yearly for 50 years

• genotype-phenotype correlation for patients with familial lipodystrophy

  every 5 years for 50 years

• age at onset of metabolic complications

  yearly for 50 years

• age at onset orthopedic complications

  yearly for 50 years

• age at onset neuromuscular complications

  yearly for 50 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all patients with lipodystrophy not due to anti-retroviral drugs presenting to a participating center might be entered

You may qualify if:

• lipodystrophy

You may not qualify if:

• lipodystrophy due to anti-retroviral drugs

Sponsors & Collaborators

• University of Ulm: lead
• Sorbonne University: collaborator
• University Hospital, Lille: collaborator
• University of Cambridge: collaborator
• Endocrinology Research Centre, Moscow: collaborator
• University of Leipzig: collaborator
• University of Amsterdam: collaborator
• Dokuz Eylul University: collaborator
• IRCCS Azienda Ospedaliero-Universitaria di Bologna: collaborator
• University of Rome Tor Vergata: collaborator
• University of Pisa: collaborator
• University of Santiago de Compostela: collaborator
• Università degli Studi del Piemonte Orientale Amedeo Avogadro: collaborator
• University Hospital Muenster: collaborator
• Szeged University: collaborator
• Centro Hospitalar do Porto: collaborator
• University Medical Centre Ljubljana: collaborator
• Medical University of Vienna: collaborator
• National and Kapodistrian University of Athens: collaborator
• Stoffwechselzentrum St. Gallen: collaborator
• National Taiwan University Hospital: collaborator
• Marmara University: collaborator
• University of Palermo: collaborator
• Attikon Hospital: collaborator
• Kinderkrankenhaus auf der Bult: collaborator
• Hopital Universitaire Robert-Debre: collaborator
• University of Milan: collaborator
• C.I. Parhon National Institute of Endocrinology: collaborator

Study Sites (28)

Medical University of Vienna

Vienna, Austria

RECRUITING

Lille University

Lille, France

RECRUITING

AP-HP Nord Université de Paris, Hôpital Universitaire Robert-Debré

Paris, France

RECRUITING

Pierre et Marie Curie School of Medicine, Sorbonne University

Paris, France

RECRUITING

Kinder-und Jugendkrankenhaus AUF DER BULT

Hanover, Germany

RECRUITING

Department of Internal Medicine (Endocrinology and Nephrology), University of Leipzig

Leipzig, Germany

RECRUITING

Med. Klinik B für Gastroenterologie und Hepatologie, Universitätsklinikum Münster

Münster, 48149, Germany

RECRUITING

Dept for Pediatrics and Adolescent Medicine, University of Ulm: Interdisciplinary obesity clinic

Ulm, 89075, Germany

RECRUITING

National and Kapodistrian University of Athens

Athens, Greece

RECRUITING

Second Department of Internal Medicine, Medical School, National and Kapodistrian University of Athens, Attikon University Hospital

Athens, Greece

RECRUITING

University of Szeged, Department of Internal Medicine

Szeged, Hungary

RECRUITING

Endocrinology Unit, Department of Clinical and Medical science, S. Orsola-Malpighi Hospital , University of Bologna

Bologna, Italy

RECRUITING

Policlinic University Hospital of Milan

Milan, Italy

RECRUITING

Universita del piemonte Orientale

Novara, Italy

RECRUITING

Palermo University

Palermo, Italy

RECRUITING

Endocrine Unit of University Hospital of Pisa

Pisa, Italy

RECRUITING

Tor Vergata University - Policlinico of Tor Vergata

Roma, Italy

RECRUITING

Academic Medical Center, University of Amsterdam

Amsterdam, Netherlands

RECRUITING

Abel Salazar Biomedical Sciences Institute - University of Porto

Porto, Portugal

RECRUITING

C. I. Parhon National Institute of Endocrinology, Bucharest, Romania

Bucharest, Romania

RECRUITING

Endocrinology Research Centre

Moscow, Russia

RECRUITING

University Medical Center Ljubljana - Clinical Institute of Medical Genetics

Ljubljana, Slovenia

RECRUITING

Santiago de Compostela University

Santiago de Compostela, Spain

RECRUITING

Stoffwechselzentrum friendlydocs

Sankt Gallen, Switzerland

RECRUITING

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Marmara University, Pediatric Endocrinology and Diabetes

Istanbul, Turkey (Türkiye)

RECRUITING

Dokuz Eylul University School of Medicine

Izmir, Turkey (Türkiye)

RECRUITING

University of Cambridge Metabolic Research Laboratories

Cambridge, United Kingdom

RECRUITING

Related Publications (1)

• von Schnurbein J, Adams C, Akinci B, Ceccarini G, D'Apice MR, Gambineri A, Hennekam RCM, Jeru I, Lattanzi G, Miehle K, Nagel G, Novelli G, Santini F, Santos Silva E, Savage DB, Sbraccia P, Schaaf J, Sorkina E, Tanteles G, Vantyghem MC, Vatier C, Vigouroux C, Vorona E, Araujo-Vilar D, Wabitsch M. European lipodystrophy registry: background and structure. Orphanet J Rare Dis. 2020 Jan 15;15(1):17. doi: 10.1186/s13023-020-1295-y.

  PMID: 31941540 BACKGROUND

MeSH Terms

Conditions

Lipodystrophy, Familial Partial; Lipodystrophy

Condition Hierarchy (Ancestors)

Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism, Inborn Errors; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Martin Wabitsch, Prof. Dr.

  University of Ulm

  STUDY CHAIR

• David Araujo-Vilar, Prof. Dr.

  Santiago de Compostela University

  PRINCIPAL INVESTIGATOR

• Julia von Schnurbein, Dr.

  University of Ulm

  PRINCIPAL INVESTIGATOR

• Gabriele Nagel, Prof.

  University of Ulm

  PRINCIPAL INVESTIGATOR

• Camille Vatier, Dr.

  Pierre et Marie Curie School of Medicine (Paris)

  PRINCIPAL INVESTIGATOR

• Marie-Christine Vantyghem, Prof.

  Lille University

  PRINCIPAL INVESTIGATOR

• Giovanni Ceccarini, Dr.

  Endocrine Unit, University Hospital of Pisa

  PRINCIPAL INVESTIGATOR

• David Savage, Prof.

  University of Cambridge Metabolic Research Laboratories

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia von Schnurbein, Dr.

CONTACT

0049 731 500; julia.schnurbein@uniklinik-ulm.de

Martin Wabitsch, Prof. Dr.

CONTACT

0049 731 500; martin.wabitsch@uniklinik-ulm.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 50 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: June 12, 2018
• Study Start: December 16, 2017
• Primary Completion (Estimated): January 1, 2068
• Study Completion (Estimated): January 1, 2068
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: As soon as data is entered into the registry, request for data analysis can be handed in.
• Access Criteria: Researchers participating in the ECLip registry and independent third parties can request to perform research with the data. For this a formal request for data analysis (data evaluation form; available from the Registry Board) has to be handed to the leader of the Registry Board who will pass it to all board members. These will form a proposal for the Registry members.

Locations

AU (1); RO (1); ES (1); HU (1); SL (1); FR (3); TW (1); NL (1); DE (4); CH (1); TU (2); GB (1); GR (2); IT (6); PT (1); RU (1)