NUTRISCLER: Assessment of Nutritional Status in Systemic Sclerosis
Study Details
Study Description
Brief Summary
The main theme of the cohort of systemic sclerosis (SSc) patients is the determination of nutritional status, its evolution and the evaluation of its management in patients with scleroderma.
The main objectives are :
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To determine the incidence of malnutrition and its main determinants (disease characteristics, severity, eating habits, physical activity) in patients with scleroderma.
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| SSc patients
|
Other: Collection of data
different set of data will be collected over a 6 months period
|
Outcome Measures
Primary Outcome Measures
- Incidence of malnutrition [6 months]
Incidence of malnutrition will be measured as a loss of more than 10% of body weight or a body mass index (BMI) less than 21 kg/m2
- Idetification of risk factors associated with malnutrition [6 months]
Collection of data related to SSc disease burden
- Success of the nutritional intervention [6 months]
body weight gain > 5%
Eligibility Criteria
Criteria
Inclusion Criteria:
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All SSc patients aged 18 or more
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Patient followed at the Montpellier University Hospital
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Patients must fulfil the American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) 2013 criteria for SSc.
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Health insurance (affiliation to social security)
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Collection of non-opposition to participate in the study
Exclusion Criteria:
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Patient under the protection of justice curatorship / guardianship;
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Patients who have already planned to move out of the region in the next two years, making the follow-up impossible.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Montpellier University Hospital | Montpellier | France |
Sponsors and Collaborators
- University Hospital, Montpellier
Investigators
- Principal Investigator: Alexandre MARIA, Montpellier University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RECHMPL19_0409
- UF7840