Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2020-06-12
2024-10-12
Brief Summary
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The main objectives are :
* To determine the incidence of malnutrition and its main determinants (disease characteristics, severity, eating habits, physical activity) in patients with scleroderma.
* For patients with undernutrition at inclusion or at 18 months follow-up:
evaluate the impact of a standardized nutritional intervention (dietary advice, oral supplements, artificial, enteral or parenteral nutrition) on nutritional and disease parameters.
Follow-up visits will take place every 6 months for 2 years. (M6, M12, M18 et M24).
During each visit: a clinical examination, with anthropometric measurements, a 3-day dietary survey and a blood sample (10 ml), completion a multiple-choice of quality of life and physical activity evaluation.
Paraclinical evaluation : echocardiography, lung function tests, screening for osteoporosis (M6 and M18).
If undernutrition is detected during a follow-up visit, the subject will be referred to a specialized service.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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SSc patients
Collection of data
different set of data will be collected over a 6 months period
Interventions
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Collection of data
different set of data will be collected over a 6 months period
Eligibility Criteria
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Inclusion Criteria
* Patient followed at the Montpellier University Hospital
* Patients must fulfil the American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) 2013 criteria for SSc.
* Health insurance (affiliation to social security)
* Collection of non-opposition to participate in the study
Exclusion Criteria
* Patients who have already planned to move out of the region in the next two years, making the follow-up impossible.
18 Years
ALL
No
Sponsors
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University Hospital, Montpellier
OTHER
Responsible Party
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Principal Investigators
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Alexandre MARIA
Role: PRINCIPAL_INVESTIGATOR
Montpellier University Hospital
Locations
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Montpellier University Hospital
Montpellier, , France
Countries
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Central Contacts
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Facility Contacts
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Alexandre MARIA
Role: primary
Other Identifiers
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UF7840
Identifier Type: OTHER
Identifier Source: secondary_id
RECHMPL19_0409
Identifier Type: -
Identifier Source: org_study_id
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