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NCT07277491 | RECRUITING | Spondyloarthritis (SpA)


Assessment of Nutritional Status in Rheumatic Diseases and Association to Disease Activity
Sponsor:

Cairo University

Information provided by (Responsible Party):

Reem Mahmoud Lotfy

Brief Summary:

The aim of the present work is to assess the nutritional status among different rheumatic diseases patients and to study its association with the corresponding diseases activity.

Condition or disease

Spondyloarthritis (SpA)

Psoriatic Arthritis (PsA)

Systemic Lupus Erythematous (SLE)

Systemic Sclerosis (SSc)

Rheumatoid Arthritis (RA

Detailed Description:

Rheumatoid arthritis (RA) is an autoimmune, progressive, systemic disease of connective tissue. It is characterized by arthritis (symmetrical in most cases), extra-articular and systemic change. Spondyloarthritis (SpA) is an interconnected group of rheumatic disorders including ankylosing spondylitis (AS) and psoriatic arthritis (PsA), characterized by common clinical symptoms and a similar genetic background .Systemic Lupus Erythematous (SLE) is a chronic connective tissue disease characterized by a multi-system inflammatory disorder with immune system imbalance .Systemic sclerosis (SSc) is an immune-mediated rheumatic disease characterized by fibrosis of the skin and internal organs as well as vasculopathy . Nutritional status has been widely related to immunity; under-nutrition is associated with immunosuppression and increased susceptibility to infection whereas over-nutrition is associated with low-grade chronic inflammation increasing the risk and affecting the prognosis in metabolic, cardiovascular, and autoimmune diseases . Patients with rheumatic diseases are prone to develop malnutrition as their medications often affect appetite, nutrient absorption and digestion.Despite the high incidence of malnutrition and its consequences, there is no universally accepted definition for diagnosing nutritional deficiencies, and nutritional assessment still relies on analyses of a combination of several anthropometric, biochemical, immunological, functional and body composition data, in addition to dietary intake and the evaluation of clinical status. Four malnutrition diagnostic tools are currently used in adults: Subjective Global Assessment (SGA) ; Mini Nutritional Assessment (MNA) ; Academy of Nutrition and Dietetics/American Society for Parenteral and Enteral Nutrition malnutrition consensus characteristics; and Global Leadership Initiative on Malnutrition criteria. Certain objective nutritional assessment indices reflect the immune nutritional status of patients, such as the prognostic nutritional index (PNI) ; and the nutritional risk index (NRI) which are calculated using serum albumin level and lymphocyte count, were found to be related to the nutritional status and disease activity in SLE patients .

Study Type : OBSERVATIONAL
Estimated Enrollment : 460 participants
Official Title : Assessment of Nutritional Status in Rheumatic Diseases and Association to Disease Activity
Actual Study Start Date : 2023-01-01
Estimated Primary Completion Date : 2025-12-30
Estimated Study Completion Date : 2025-12-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • Patients diagnosed with rheumatic diseases including RA, SpA, SLE and SSc.
Exclusion Criteria
  • 1. Patients who are unable to comply with the physician assessment.
  • 2. Patients with other connective tissue diseases, neurological diseases, malignancy, heart failure or severe renal dysfunction was excluded, as these diseases affect the muscle mass causing sarcopenia.
  • 3. Advanced liver diseases

Assessment of Nutritional Status in Rheumatic Diseases and Association to Disease Activity

Location Details

NCT07277491


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Locations


RECRUITING

Egypt,

Department: Rheumatology and Rehabilitation Department, Faculty of Medicine, Cairo University

Cairo, Egypt, 12613

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