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

NCT07277491 | Recruiting

• 1 other identifier: MD-66-2023
• Study Type: observational
• Target: 460
• Locations: 1 country
• Sites: 1

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.

Conditions

Spondyloarthritis (SpA); Psoriatic Arthritis (PsA); Systemic Lupus Erythematous (SLE); Systemic Sclerosis (SSc); Rheumatoid Arthritis (RA

Keywords

nutritional status; rheumatic diseases; disease activity

Outcome Measures

Primary Outcomes (4)

• Nutritional Status as Assessed by the Prognostic Nutritional Index (PNI)

  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

  Assessed during routine clinic visits between January 1, 2023, and December 30, 2025.

• Nutritional Risk as Assessed by the Nutritional Risk Index (NRI)

  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

  Assessed during routine clinic visits between January 1, 2023, and December 30, 2025.

• Nutritional Status as Assessed by the Subjective Global Assessment (SGA)

  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.

  Assessed during routine clinic visits between January 1, 2023, and December 30, 2025.

• Nutritional Status as Assessed by the Mini Nutritional Assessment - Short Form (MNA-SF)

  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).

  Assessed during routine clinic visits between January 1, 2023, and December 30, 2025

Secondary Outcomes (5)

• 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.

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Population of study: Patients of both genders were recruited in this study. Study subjects were patients with different rheumatic diseases attending the outpatient Rheumatology Clinic. Patients who visited the clinic from January 2023 to December 2025 were asked to participate after being provided with an explanation of the work. Study location: Study was conducted in the outpatient clinics of the Rheumatology Department, Cairo University Hospitals as well as in the Health Insurance Hospital, Aswan Governorate.

You may qualify if:

• Patients diagnosed with rheumatic diseases including RA, SpA, SLE and SSc.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

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

Cairo, 12613, Egypt

RECRUITING

Related Publications (10)

• Liu H, Jiao J, Zhu M, Wen X, Jin J, Wang H, Lv D, Zhao S, Sun X, Wu X, Xu T. Nutritional Status According to the Short-Form Mini Nutritional Assessment (MNA-SF) and Clinical Characteristics as Predictors of Length of Stay, Mortality, and Readmissions Among Older Inpatients in China: A National Study. Front Nutr. 2022 Jan 25;9:815578. doi: 10.3389/fnut.2022.815578. eCollection 2022.

  PMID: 35145987 BACKGROUND

• Olsen MN, Tangvik RJ, Halse AK. Evaluation of Nutritional Status and Methods to Identify Nutritional Risk in Rheumatoid Arthritis and Spondyloarthritis. Nutrients. 2020 Nov 21;12(11):3571. doi: 10.3390/nu12113571.

  PMID: 33233336 BACKGROUND

• Malone A, Mogensen KM. Key approaches to diagnosing malnutrition in adults. Nutr Clin Pract. 2022 Feb;37(1):23-34. doi: 10.1002/ncp.10810. Epub 2021 Dec 22.

  PMID: 34936131 BACKGROUND

• Klak A, Borowicz J, Manczak M, Grygielska J, Samel-Kowalik P, Raciborski F. Current nutritional status of patients with rheumatic diseases in the population of Poland. Reumatologia. 2015;53(1):26-33. doi: 10.5114/reum.2015.50554. Epub 2015 Apr 10.

  PMID: 27407222 BACKGROUND

• Vellas B, Guigoz Y, Garry PJ, Nourhashemi F, Bennahum D, Lauque S, Albarede JL. The Mini Nutritional Assessment (MNA) and its use in grading the nutritional state of elderly patients. Nutrition. 1999 Feb;15(2):116-22. doi: 10.1016/s0899-9007(98)00171-3.

  PMID: 9990575 BACKGROUND

• Detsky AS, McLaughlin JR, Baker JP, Johnston N, Whittaker S, Mendelson RA, Jeejeebhoy KN. What is subjective global assessment of nutritional status? JPEN J Parenter Enteral Nutr. 1987 Jan-Feb;11(1):8-13. doi: 10.1177/014860718701100108.

  PMID: 3820522 BACKGROUND

• Alwall N. Historical perspective on the development of the artificial kidney. Artif Organs. 1986 Apr;10(2):86-99. doi: 10.1111/j.1525-1594.1986.tb02526.x. No abstract available.

  PMID: 3521553 BACKGROUND

• Correa-Rodriguez M, Pocovi-Gerardino G, Callejas-Rubio JL, Fernandez RR, Martin-Amada M, Cruz-Caparros MG, Ortego-Centeno N, Rueda-Medina B. The Prognostic Nutritional Index and Nutritional Risk Index Are Associated with Disease Activity in Patients with Systemic Lupus Erythematosus. Nutrients. 2019 Mar 16;11(3):638. doi: 10.3390/nu11030638.

  PMID: 30884776 BACKGROUND

• Aparicio-Soto M, Sanchez-Hidalgo M, Alarcon-de-la-Lastra C. An update on diet and nutritional factors in systemic lupus erythematosus management. Nutr Res Rev. 2017 Jun;30(1):118-137. doi: 10.1017/S0954422417000026. Epub 2017 Mar 15.

  PMID: 28294088 BACKGROUND

• Allanore Y, Simms R, Distler O, Trojanowska M, Pope J, Denton CP, Varga J. Systemic sclerosis. Nat Rev Dis Primers. 2015 Apr 23;1:15002. doi: 10.1038/nrdp.2015.2.

  PMID: 27189141 BACKGROUND

MeSH Terms

Conditions

Spondylarthritis; Arthritis, Psoriatic; Scleroderma, Systemic; Arthritis, Rheumatoid; Rheumatic Diseases

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Spondylarthropathies; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Dina Ossama Abdulazim, assistant professor

  Rheumatology and Rehabilitation Department, Faculty of Medicine, Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reem Mahmoud Lotfy, Rheumatology Specialist

CONTACT

+201091940005; reemaaz2000@yahoo.com

Tamer Atef Gheita, Professor of rheumatology

CONTACT

+201004567975; gheitamer@cu.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 5 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rheumatology Specialist

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: December 11, 2025
• Study Start: January 1, 2023
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

EG (1)