Registry for Patients With Lipodystrophy (ECLip Registry)

November 24, 2025 updated by: Julia von Schnurbein, University of Ulm

Osse Registry for Patients With Lipodystrophy Run by the European Consortium of Lipodystrophies (ECLip)

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

As lipodystrophies are rare diseases subdivided into yet rarer sub-groups, research in this field requires international co-operation.

The European Consortium of Lipodystrophy (ECLip) consists of an association of European experts in the field of lipodystrophy. It has set up a Registry Board to implement a registry for patients with lipodystrophy using the Open Source Software OSSE (Open Source Registry System for Rare Diseases in the EU), which is a web based platform focused on a federated approach that allows to perform distributed searches which are designed to comply data protection requirements and preserve data sovereignty. To ensure data protection, medical and identifying data will be stored on two different servers both run by the Institute for Epidemiology and Medical Biometry of the University of Ulm.

Medical centers from all over the world where patients are treated with lipodystrophy are invited to join the ECLip Registry and to become ECLip Registry members. Upon registration, they can enter patient data after they have obtained local ethic committee permission and the patient in question has given written consent to this. Data entry is done at the individual locations via a web-based user interface. Identifying data are recorded directly into the identity management system. Communication between the identity management and the OSSE registry happens via a web browser.

The aim of the patient registry is to compile data on the natural history of each different sub-group of lipodystrophies, their comorbidities, treatment options used and medical and quality of life out-come for the patients. For this, the following data retrieved from regular patient visits are collected:

  • Precise diagnosis including moleculargenetic results
  • Clinical presentation and comorbidities
  • Laboratory changes and results of diagnostic procedures
  • Natural course of the disease including age at onset of disease and comorbidities
  • Family history

Research within this registry can be performed by participating clinicians/researchers and third parties after a research proposal has be accepted by the responsible committee of the ECLip. The registry aims to answer the following questions

  • new insights into the pathophysiology of lipodystrophy
  • improve therapeutic options for the patients
  • compile information material for patients, families and relevant professionals

Study Type

Observational

Enrollment (Estimated)

5000

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

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

Description

Inclusion Criteria:

  • lipodystrophy

Exclusion Criteria:

  • lipodystrophy due to anti-retroviral drugs

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Age at death
Time Frame: after 20 years
patients are followed regularly, age at death (years) will be documented
after 20 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in somatic comorbidities under standard treatment
Time Frame: yearly for 50 years
standardized physical examination, laboratory and instrument based tests
yearly for 50 years
genotype-phenotype correlation for patients with familial lipodystrophy
Time Frame: every 5 years for 50 years
molecular genetic results will be compared to results from standardized physical examination, laboratory and instrument based tests
every 5 years for 50 years
age at onset of metabolic complications
Time Frame: yearly for 50 years
metabolic complications will be assessed via standardized physical examination, laboratory and instrument based tests
yearly for 50 years
age at onset orthopedic complications
Time Frame: yearly for 50 years
orthopedic complications will be assessed via standardized physical examination, laboratory and instrument based tests
yearly for 50 years
age at onset neuromuscular complications
Time Frame: yearly for 50 years
neuromuscular complications will be assessed via standardized physical examination, laboratory and instrument based tests
yearly for 50 years

Collaborators and Investigators

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

Sponsor

University of Ulm

Collaborators

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

Investigators

  • Study Chair: Martin Wabitsch, Prof. Dr., University of Ulm
  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 16, 2017

Primary Completion (Estimated)

January 1, 2068

Study Completion (Estimated)

January 1, 2068

Study Registration Dates

First Submitted

March 14, 2018

First Submitted That Met QC Criteria

June 11, 2018

First Posted (Actual)

June 12, 2018

Study Record Updates

Last Update Posted (Estimated)

December 2, 2025

Last Update Submitted That Met QC Criteria

November 24, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECLip Registry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Researches participating in the ECLip registry and third parties independently can request to perform research with the data.

IPD Sharing Time Frame

As soon as data is entered into the registry, request for data analysis can be handed in.

IPD Sharing 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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