Informations générales (source: ClinicalTrials.gov)
Assessment of Nutritional Status in Systemic Sclerosis: Prospective Cohort Study in Montpellier University Hospital (NUTRISCLER)
Observational
University Hospital, Montpellier (Voir sur ClinicalTrials)
juin 2020
octobre 2024
10 mai 2025
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 :
- 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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Montpellier University Hospital - Montpellier - France | Alexandre MARIA | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- All SSc patients aged 18 or more
- 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
- All SSc patients aged 18 or more
- 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
- Patient under the protection of justice curatorship / guardianship;
- Patients who have already planned to move out of the region in the next two years,
making the follow-up impossible.