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| ID | Type | Description | Link |
|---|---|---|---|
| UF7840 | Other Identifier | Montpellier University Hospital |
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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 :
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SSc patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collection of data | Other | different set of data will be collected over a 6 months period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of malnutrition | 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 | 6 months |
| Idetification of risk factors associated with malnutrition | Collection of data related to SSc disease burden | 6 months |
| Success of the nutritional intervention | body weight gain > 5% | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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The study population is patients aged 18 or more with scleroderma. From preliminary data obtained in our department, we can estimate that 50% of participants will meet the definition of malnutrition (BMI<21kg/m2 or weigh loss >10% in months) at baseline.
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| Name | Affiliation | Role |
|---|---|---|
| Alexandre MARIA | Montpellier University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montpellier University Hospital | Montpellier | France |
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| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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