Lipodystrophy AcquiredECLip RegistryNCT03553420
Registry for Patients With Lipodystrophy
An observational study of Lipodystrophy Acquired and Lipodystrophy Congenital, run by University of Ulm at 28 sites in 16 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lipodystrophy Acquired, Lipodystrophy Congenital
- How many people
- 5,000 participants
- Where
- 28 sitesin 16 countries
- Study dates
- 16 Dec 2017to Jan 2068
- How long will I take part?
- 50 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all patients with lipodystrophy not due to anti-retroviral drugs presenting to a participating center might be entered
Who may be able to join
- lipodystrophy
Who cannot join
- lipodystrophy due to anti-retroviral drugs
Trial locations and contacts
28 sites in 16 countries. Contact the study team or a site near you to ask about taking part.
28 sites in 16 countries
Italy6 sites, 6 recruiting
- Recruiting
Endocrinology Unit, Department of Clinical and Medical science, S. Orsola-Malpighi Hospital , University of Bologna
Bologna
Alessandra Gambineri, Ass. Prof., alessandra.gambineri@aosp.bo.it
Giovanna Lattanzi, lattanzi@area.bo.cnr.it
- Recruiting
Policlinic University Hospital of Milan
Milan
Giulia Rodari, Dr., giulia.rodari@policlinico.mi.it
- Recruiting
Universita del piemonte Orientale
Novara
Flavia Prodam, Dr, flavia.prodam@med.uniupo.it
Gianluca Aimaretti, Prof, gianluca.aimaretti@med.uniupo.it
- Recruiting
Palermo University
Palermo
Silvio Buscemi, Prof., silvio.buscemi@unipa.it
- Recruiting
Endocrine Unit of University Hospital of Pisa
Pisa
Giovanni Ceccarini, Prof. Dr., giovanni.ceccarini@unipi.it
Ferruccio Santini, Prof. Dr., +39 050 544 ext. 723, ferruccio.santini@med.unipi.it
- Recruiting
Tor Vergata University - Policlinico of Tor Vergata
Roma
Giusepe Novelli, Prof, novelli@med.uniroma2.it
Maria Rosaria D'Apice, Dr, d.apice@med.uniroma2.it
Germany4 sites, 4 recruiting
- Recruiting
Kinder-und Jugendkrankenhaus AUF DER BULT
Hanover
Jantje Weiskorn, Dr., weiskorn@hka.de
- Recruiting
Department of Internal Medicine (Endocrinology and Nephrology), University of Leipzig
Leipzig
Konstanze Miehle, Dr., Konstanze.Miehle@medizin.uni-leipzig.de
Michael Stumvoll, Prof. Dr.
- Recruiting
Med. Klinik B für Gastroenterologie und Hepatologie, Universitätsklinikum Münster
Münster, 48149
Hartmut Schmidt, Prof., hepar@ukmuenster.de
Elena Vorona, Dr. med., Elena.Vorona@ukmuenster.de
- Recruiting
Dept for Pediatrics and Adolescent Medicine, University of Ulm: Interdisciplinary obesity clinic
Ulm, 89075
Martin Wabitsch, Prof. Dr., 0049 731 500 ext. 57401, martin.wabitsch@uniklinik-ulm.de
Julia von Schnurbein, Dr. med., 0049 731 500 ext. 57401, julia.schnurbein@uniklinik-ulm.de
France3 sites, 3 recruiting
- Recruiting
Lille University
Lille
Marie-Christine Vantyghem, Prof., marie-christine.vantyghem@chru-lille.fr
Géraldine Lavergne
- Recruiting
AP-HP Nord Université de Paris, Hôpital Universitaire Robert-Debré
Paris
Elise Bismuth, Dr., elise.bismuth@aphp.fr
- Recruiting
Pierre et Marie Curie School of Medicine, Sorbonne University
Paris
Camille Vatier, Dr., camille.vatier@aphp.fr
Corinne Vigouroux, Prof. Dr., corinne.vigouroux@inserm.fr
Greece2 sites, 2 recruiting
- Recruiting
National and Kapodistrian University of Athens
Athens
Alexandraki, Prof., alexandrakik@gmail.com
Spyroglou, Prof., aspyroglou@yahoo.com
- Recruiting
Second Department of Internal Medicine, Medical School, National and Kapodistrian University of Athens, Attikon University Hospital
Athens
Vaia Lambadiari, Prof., vlambadiari@gmail.com
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Marmara University, Pediatric Endocrinology and Diabetes
Istanbul
Belma Haliloglu, Prof., belmahaliloglu26@hotmail.com
- Recruiting
Dokuz Eylul University School of Medicine
Izmir
Baris Akinci, barisakincimd@gmail.com
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna
Thomas Scherer, M.D., thomas.scherer@meduniwien.ac.at
Marianna Beghini, M.D., marianna.beghini@meduniwien.ac.at
Hungary1 site, 1 recruiting
- Recruiting
University of Szeged, Department of Internal Medicine
Szeged
Eva Csajbok, Dr., ecsajbok@yahoo.com
Netherlands1 site, 1 recruiting
- Recruiting
Academic Medical Center, University of Amsterdam
Amsterdam
Kleinendorst Lotte, Dr., l.kleinendorst@amsterdamumc.nl
Marjoleine Broekema, Dr., m.broekema@amsterdamumc.nl
Portugal1 site, 1 recruiting
- Recruiting
Abel Salazar Biomedical Sciences Institute - University of Porto
Porto
Ermelinda Santos Silva, Prof. Dra, u20868@chporto.min-saude.pt
Romania1 site, 1 recruiting
- Recruiting
C. I. Parhon National Institute of Endocrinology, Bucharest, Romania
Bucharest
Iuliana Gherlan, iuliana.gherlan77@gmail.com
Russia1 site, 1 recruiting
- Recruiting
Endocrinology Research Centre
Moscow
Marina Shestakova, MD, shestakova.mv@gmail.com
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Center Ljubljana - Clinical Institute of Medical Genetics
Ljubljana
Karin Writzl, Dr., 003861522 ext. 6031, karinwritzl@gmail.com
Iztok Stotl, Dr
Spain1 site, 1 recruiting
- Recruiting
Santiago de Compostela University
Santiago de Compostela
David Araujo-Vilar, Prof. Dr., david.araujo@usc.es
Antía Fernández Pombo, antia.fernandez.pombo@rai.usc.es
Switzerland1 site, 1 recruiting
- Recruiting
Stoffwechselzentrum friendlydocs
Sankt Gallen
Katrin Heldt, MD, katrin.heldt@friendlydocs.ch
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Ni-Chung Lee, Dr., ncleentu@ntu.edu.tw
United Kingdom1 site, 1 recruiting
- Recruiting
University of Cambridge Metabolic Research Laboratories
Cambridge
David Savage, Prof., dbs23@medschl.cam.ac.uk
Claire Adams, ca337@medschl.cam.ac.uk
About this study
Official title: 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.
Read the 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
- Conditions
- Lipodystrophy Acquired, Lipodystrophy Congenital
- Keywords
- lipodystrophy
- Medical subject headings
- Lipodystrophy, Familial Partial, Lipodystrophy
What is being measured
The primary outcome is the main question the study is designed to answer.
Age at death
patients are followed regularly, age at death (years) will be documented
Measured: after 20 years
Secondary outcomes (5)
change in somatic comorbidities under standard treatment
standardized physical examination, laboratory and instrument based tests
Measured: yearly for 50 years
genotype-phenotype correlation for patients with familial lipodystrophy
molecular genetic results will be compared to results from standardized physical examination, laboratory and instrument based tests
Measured: every 5 years for 50 years
age at onset of metabolic complications
metabolic complications will be assessed via standardized physical examination, laboratory and instrument based tests
Measured: yearly for 50 years
age at onset orthopedic complications
orthopedic complications will be assessed via standardized physical examination, laboratory and instrument based tests
Measured: yearly for 50 years
age at onset neuromuscular complications
neuromuscular complications will be assessed via standardized physical examination, laboratory and instrument based tests
Measured: yearly for 50 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start16 Dec 2017
- Primary completionJan 2068 (estimated)
- Study completionJan 2068 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lipodystrophy AcquiredStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 50 Years
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Collaborators
- Sorbonne University, University Hospital, Lille, University of Cambridge, Endocrinology Research Centre, Moscow, University of Leipzig, University of Amsterdam, Dokuz Eylul University, IRCCS Azienda Ospedaliero-Universitaria di Bologna, University of Rome Tor Vergata, University of Pisa, University of Santiago de Compostela, Università degli Studi del Piemonte Orientale Amedeo Avogadro, University Hospital Muenster, Szeged University, Centro Hospitalar do Porto, University Medical Centre Ljubljana, Medical University of Vienna, National and Kapodistrian University of Athens, Stoffwechselzentrum St. Gallen, National Taiwan University Hospital, Marmara University, University of Palermo, Attikon Hospital, Kinderkrankenhaus auf der Bult, Hopital Universitaire Robert-Debre, University of Milan, C.I. Parhon National Institute of Endocrinology
- Responsible party
- Principal investigator, Julia von Schnurbein, University of Ulm
- Investigators
- Martin Wabitsch, Prof. Dr., Study chair, University of UlmDavid Araujo-Vilar, Prof. Dr., Principal investigator, Santiago de Compostela UniversityJulia von Schnurbein, Dr., Principal investigator, University of UlmGabriele Nagel, Prof., Principal investigator, University of UlmCamille Vatier, Dr., Principal investigator, Pierre et Marie Curie School of Medicine (Paris)Marie-Christine Vantyghem, Prof., Principal investigator, Lille UniversityGiovanni Ceccarini, Dr., Principal investigator, Endocrine Unit, University Hospital of PisaDavid Savage, Prof., Principal investigator, University of Cambridge Metabolic Research Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03553420
- Sponsor's protocol ID
- ECLip Registry
- Acronym
- ECLip Registry
- Status last verified
- Nov 2025
- First submitted
- 14 Mar 2018
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researches participating in the ECLip registry and third parties independently can request to perform research with the data.
Publications
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.
PubMed 31941540
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osse Registry for Patients With Lipodystrophy Run by the European Consortium of Lipodystrophies (ECLip)
- ClinicalTrials.gov ID
- NCT03553420
- Acronym / sponsor ID
- ECLip Registry / ECLip Registry
- Conditions
- Lipodystrophy Acquired, Lipodystrophy Congenital
- Keywords
- lipodystrophy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Collaborators
- Sorbonne University, University Hospital, Lille, University of Cambridge, Endocrinology Research Centre, Moscow, University of Leipzig, University of Amsterdam, Dokuz Eylul University, IRCCS Azienda Ospedaliero-Universitaria di Bologna, University of Rome Tor Vergata, University of Pisa, University of Santiago de Compostela, Università degli Studi del Piemonte Orientale Amedeo Avogadro, University Hospital Muenster, Szeged University, Centro Hospitalar do Porto, University Medical Centre Ljubljana, Medical University of Vienna, National and Kapodistrian University of Athens, Stoffwechselzentrum St. Gallen, National Taiwan University Hospital, Marmara University, University of Palermo, Attikon Hospital, Kinderkrankenhaus auf der Bult, Hopital Universitaire Robert-Debre, University of Milan, C.I. Parhon National Institute of Endocrinology
- Study start
- 16 Dec 2017 (actual)
- Primary completion
- Jan 2068 (estimated)
- Study completion
- Jan 2068 (estimated)
- First posted
- 12 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 50 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patients with lipodystrophy not due to anti-retroviral drugs presenting to a participating center might be entered
Key inclusion criteria (1 listed)
- lipodystrophy
Key exclusion criteria (1 listed)
- lipodystrophy due to anti-retroviral drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Age at death
Time frame: after 20 years
patients are followed regularly, age at death (years) will be documented
5 secondary outcomes
change in somatic comorbidities under standard treatment
Time frame: yearly for 50 years
genotype-phenotype correlation for patients with familial lipodystrophy
Time frame: every 5 years for 50 years
age at onset of metabolic complications
Time frame: yearly for 50 years
age at onset orthopedic complications
Time frame: yearly for 50 years
age at onset neuromuscular complications
Time frame: yearly for 50 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Background: PubMed 31941540von 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.
- Individual participant dataSharing planned: Yes. Researches participating in the ECLip registry and third parties independently can request to perform research with the data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martin Wabitsch, Prof. Dr. study chair
University of Ulm
David Araujo-Vilar, Prof. Dr. principal investigator
Santiago de Compostela University
Julia von Schnurbein, Dr. principal investigator
University of Ulm
28 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lipodystrophy Acquired and Lipodystrophy Congenital, run by University of Ulm at 28 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Italy, Germany, France, Greece, Turkey (Türkiye) and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julia von Schnurbein, Dr. (0049 731 500 ext. 57401, julia.schnurbein@uniklinik-ulm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age at death (time frame: after 20 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03553420, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.