Assessment of Nutritional Status in Rheumatic Diseases and Association to Disease Activity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 460
- 试验地点
- 1
- 主要终点
- Nutritional Risk as Assessed by the Nutritional Risk Index (NRI)
研究概览
简要总结
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.
详细描述
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 .
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients diagnosed with rheumatic diseases including RA, SpA, SLE and SSc.
排除标准
- •Patients who are unable to comply with the physician assessment.
- •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.
- •Advanced liver diseases
研究组 & 干预措施
cases with different rheumatic diseases
135 patients with different rheumatic diseases who attended the outpatient Rheumatology Clinic, Cairo University Hospitals as well as the Health Insurance Hospital, Aswan Governorate Patients diagnosed with rheumatic diseases including RA,SpA,SLE and SSc were included
control cases matched for age and sex
control cases selected from healthy volunteers matched for age and sex
结局指标
主要结局
Nutritional Risk as Assessed by the Nutritional Risk Index (NRI)
时间窗: Assessed during routine clinic visits between January 1, 2023, and December 30, 2025.
The Nutritional Risk Index (NRI) is an index score calculated based on serum albumin levels and the percentage of weight loss. Unit of Measure: Calculated Index Score Interpretation: Higher scores indicate a lower nutritional risk
Nutritional Status as Assessed by the Subjective Global Assessment (SGA)
时间窗: Assessed during routine clinic visits between January 1, 2023, and December 30, 2025.
The Subjective Global Assessment (SGA) is a clinical tool that results in a score based on a patient questionnaire and physical examination. Unit of Measure: Score on a 7-point scale Interpretation: Higher scores indicate better nutritional status.
Nutritional Status as Assessed by the Prognostic Nutritional Index (PNI)
时间窗: Assessed during routine clinic visits between January 1, 2023, and December 30, 2025.
The Prognostic Nutritional Index (PNI) is an index score calculated using the formula: Serum Albumin (g/L) + 5 × Total Lymphocyte Count (/mm³). Unit of Measure: Calculated Index Score Interpretation: Higher scores indicate better nutritional status
Nutritional Status as Assessed by the Mini Nutritional Assessment - Short Form (MNA-SF)
时间窗: Assessed during routine clinic visits between January 1, 2023, and December 30, 2025
The Mini Nutritional Assessment - Short Form (MNA-SF) is a screening tool consisting of a questionnaire administered to the patient. Unit of Measure: Score on a 14-point scale Interpretation: Scores are categorized as: 12-14 (normal nutritional status), 8-11 (at risk of malnutrition), or 0-7 (malnourished).
次要结局
- corrolation between Body Mass Index (BMI) and disease activity(Assessed during routine clinic visits between January 1, 2023, and December 30, 2025)
- corrolation between Prognostic Nutritional Index (PNI) and disease activity(Assessed during routine clinic visits between January 1, 2023, and December 30, 2025.)
- corrolation between Nutritional Risk Index (NRI) and disease activity(Assessed during routine clinic visits between January 1, 2023, and December 30, 2025.)
- Corrolation between Nutritional Status Categorization by Subjective Global Assessment (SGA) and disease activity(Assessed during routine clinic visits between January 1, 2023, and December 30, 2025.)
- Duration of Rheumatic Disease(Assessed during routine clinic visits between January 1, 2023, and December 30, 2025.)
研究者
Reem Mahmoud Lotfy
Rheumatology Specialist
Cairo University