Assessment of Nutritional Status in Systemic Sclerosis

Recruiting

• Conditions: Systemic Sclerosis
• Interventions: Other: Collection of data

• Registration Number: NCT04301596
• Lead Sponsor: University Hospital, Montpellier

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 :

* 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-05
• Study First Submitted QC: 2020-03-09
• Study First Posted: 2020-03-10
• Study Start: 2020-06-12
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-02
• Last Update Posted: 2023-05-03
• Primary Completion: 2024-06-12
• Study Completion: 2024-10-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SSc patients	Collection of data	-

Primary Outcome Measures

Name	Time	Method
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%

Trial Locations

Locations (1)

Montpellier University Hospital; 🇫🇷 Montpellier, France