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Diagnostic Consistency of GLIM and PG-SGA for Malnutrition in Pancreatic Cancer

Diagnostic Consistency of the Global Leadership Initiative on Malnutrition (GLIM) Criteria and the Patient-Generated Subjective Global Assessment (PG-SGA) for Malnutrition in Patients With Pancreatic Cancer

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07057895
Enrollment
108
Registered
2025-07-10
Start date
2023-01-01
Completion date
2024-12-31
Last updated
2025-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Neoplasms

Keywords

GLIM criteria, PG-SGA, Pancreatic cancer, Malnutrition, Diagnostic consistency

Brief summary

This study aimed to evaluate the diagnostic consistency between the Global Leadership Initiative on Malnutrition (GLIM) criteria and the Patient-Generated Subjective Global Assessment (PG-SGA) for identifying malnutrition in patients with pancreatic malignant tumors. The goal is to determine if the GLIM criteria, a newer and more streamlined tool, shows substantial agreement with the well-established PG-SGA, thereby supporting its use in this high-risk clinical population.

Detailed description

Pancreatic cancer is a highly aggressive malignancy often associated with severe nutritional decline. While the Nutritional Risk Screening 2002 (NRS 2002) is used for initial screening and the Patient-Generated Subjective Global Assessment (PG-SGA) is a recognized standard for detailed nutritional assessment, the PG-SGA can be time-consuming. The Global Leadership Initiative on Malnutrition (GLIM) criteria were developed to provide a globally harmonized, two-step framework for diagnosing malnutrition. This prospective observational study was designed to compare the performance of GLIM criteria against the PG-SGA in patients with pancreatic cancer. Patients admitted to the hospital were screened with NRS 2002. Those at nutritional risk (NRS 2002 ≥ 3) were then comprehensively assessed using both PG-SGA and GLIM criteria. The study hypothesis is that the GLIM criteria and PG-SGA will demonstrate good consistency in diagnosing malnutrition in this population, validating GLIM as a practical and reliable assessment tool in clinical settings.

Interventions

DIAGNOSTIC_TESTGlobal Leadership Initiative on Malnutrition (GLIM) Criteria Assessment

Malnutrition was diagnosed according to the GLIM consensus criteria. This required at least one phenotypic criterion (non-volitional weight loss, low BMI, or reduced muscle mass) and one etiologic criterion (reduced food intake/assimilation or inflammation/disease burden). Reduced muscle mass was assessed by bioelectrical impedance analysis (BIA). The assessment was performed once for each patient within 24 hours of hospital admission.

DIAGNOSTIC_TESTPatient-Generated Subjective Global Assessment (PG-SGA)

A comprehensive nutritional assessment administered by trained clinical staff. The tool comprises patient-reported sections (weight history, food intake, symptoms, activities/function) and clinician-assessed sections (disease, metabolic demand, physical exam). For this study, a total score of ≥2 was considered indicative of malnutrition. The assessment was performed once for each patient within 24 hours of hospital admission.

Sponsors

The First Hospital of Hebei Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Histopathologically confirmed pancreatic malignant tumor. * Age ≥ 18 years. * Clear cognition and ability to communicate verbally. * Nutritional Risk Screening 2002 (NRS 2002) score ≥ 3. * Provision of written informed consent to participate.

Exclusion criteria

* Presence of severe cardiac, hepatic, or renal comorbidities. * Bedridden status precluding weight measurement. * Contraindications to bioelectrical impedance analysis (e.g., implanted electronic devices, amputation). * Concurrent diagnosis of other malignant tumors, particularly of the digestive system. * Inability to cooperate with questionnaire completion or assessments.

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic Consistency between GLIM Criteria and PG-SGAAssessed once within 24 hours of hospital admission.The consistency in diagnosing malnutrition (yes/no) between the GLIM criteria and the PG-SGA was assessed. The agreement was quantified using Cohen's kappa coefficient (κ). A kappa value of 0.61-0.80 was interpreted as substantial agreement.

Secondary

MeasureTime frameDescription
Prevalence of Malnutrition according to GLIM CriteriaAssessed once within 24 hours of hospital admission.The percentage of patients diagnosed with malnutrition based on the GLIM criteria, which requires at least one phenotypic criterion (non-volitional weight loss, low BMI, or reduced muscle mass) and one etiologic criterion (reduced food intake/assimilation or inflammation/disease burden).
Prevalence of Malnutrition according to PG-SGAAssessed once within 24 hours of hospital admission.The percentage of patients identified as malnourished based on the PG-SGA. A total score of ≥2 was considered indicative of malnutrition.
Correlation of Assessment Tools with Nutritional IndicatorsAssessed at baseline (within 24 hours of admission).The correlation between the malnutrition diagnosis (by GLIM and PG-SGA) and traditional nutritional indicators was assessed using Pearson correlation analysis. The indicators included mid-upper arm circumference (AC), calf circumference (CC), Body Mass Index (BMI), serum albumin (Alb), and hemoglobin (Hb).

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026