Analysis of the Aetiological Factors of Malnutrition

Recruiting

• Conditions: Disease-related Malnutrition; Inflammation

• Registration Number: NCT05781178
• Lead Sponsor: Endocrinology and Clinical Nutrition Research Center, Spain

Brief Summary

Disease-related malnutrition (DRM) is a frequent syndrome in clinical practice, in which the mutual relationship between disease and malnutrition is observed. Inflammation, anorexia, changes in body composition or in energy and protein requirements, contribute to the development of DRM. The Global Leadership Initiative on Malnutrition (GLIM criteria) provides a diagnostic system of malnutrition that has been accepted by the main international scientific societies in the field of clinical nutrition.

The GLIM criteria proposes an algorithm that includes phenotypic criteria (weight loss, underweight and low muscle mass), with their corresponding severity thresholds, and aetiological criteria (decreased oral intake, nutrient malabsorption and the presence of an inflammatory component). The diagnosis of malnutrition is established when an aetiological and a phenotypic criterion are met.

The aim of the study is to determine the diagnostic and prognostic value of aetiological factors of malnutrition based on GLIM criteria, presence and degree of inflammation and dietary intake, in patients diagnosed with DRM.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-28
• Study First Submitted QC: 2023-03-10
• Study First Posted: 2023-03-23
• Study Start: 2023-05-02
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-07
• Last Update Posted: 2023-09-11
• Primary Completion: 2023-12
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Diagnosis of DRM based on GLIM criteria with the presence of the aetiological criterion of inflammatory component and candidate for medical nutritional treatment according to current regulations.
• Agreeing to voluntarily participate in the study and sign the informed consent form, after having read the participant information sheet.
• Presence of an inflammatory response (CRP>3 mg/dl)
• Having an adequate cultural level and understanding of the clinical study.

Exclusion Criteria

• Pregnant or breastfeeding women
• Patients with advanced liver cirrhosis or chronic hepatitis (Child=C scale)
• Patients with advanced neoplastic disease with life expectancy <6 months
• Patients with renal insufficiency with creatinine clearance less than 45 ml/min
• Severe infection in the last 3 weeks
• Taking antibiotic therapy at the time of inclusion, with the exception of prophylactic treatments
• Taking corticosteroids at the current time or one month prior to inclusion
• Treatment with biological therapies (antibodies) at the current time or one month in advance
• Taking non-steroidal anti-inflammatory drugs at the time of inclusion
• Taking omega 3 supplements for any concomitant pathology at the time of inclusion
• Undergoing surgery during the follow-up phase of the study
• Initiation of any drug during the study phase that may modify the patient's inflammatory pattern at the investigator's discretion
• Any criterion that, in the opinion of the principal investigator, could condition the conduct of the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood biochemistry data	Patients will be followed over a period of 3 consecutive months	Platelets (x103/μL)

Secondary Outcome Measures

Name	Time	Method
Malnutrition Diagnosis	Patients will be followed over a period of 3 consecutive months	GLIM criteria (Global Leadership Initiative on Malnutrition): GLIM rank indicates the patient's nutritional status according to 3 categories: well nourished, moderate malnutrition and severe malnutrition
Oral intake	Patients will be followed over a period of 3 consecutive months	Fibre: obtained from the nutritional analysis of a two-day dietary survey using the programme https://calcdieta.ienva.org (g)
Bioelectrical impedance data (model (50 kHz)	Patients will be followed over a period of 3 consecutive months	SMI (skeletal muscle mass index, kg)
Functional parameters	Patients will be followed over a period of 3 consecutive months	Dynamometry: hree measurements of the dominant hand will be made recording the mean and maximum, measured in kilograms. Jamar® dynamometers are most used in international studies and have several grip positions

Trial Locations

Locations (15)

Complejo Hospitalario Universitario de Ferrol; 🇪🇸 Ferrol, A Coruña, Spain

Hospital Universitario Son Espases; 🇪🇸 Palma De Mallorca, Islas Baleares, Spain

Complejo Hospitalario Universitario de Vigo; 🇪🇸 Vigo, Pontevedra, Spain

Hospital Universitario Basurto; 🇪🇸 Bilbao, Vizcaya, Spain

Hospital Universitario de Badajoz; 🇪🇸 Badajoz, Spain

Hospital Universitario Virgen de las Nieves; 🇪🇸 Granada, Spain

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Hospital Universitario Virgen del Rocío; 🇪🇸 Sevilla, Spain

Hospital Universitario y Politécnico La Fe; 🇪🇸 Valencia, Spain

Complejo Hospitalario Universitario de Santiago de Compostela; 🇪🇸 Santiago De Compostela, A Coruña, Spain

Hospital Universitario Marqués de Valdecilla; 🇪🇸 Santander, Cantabria, Spain

Complejo Hospitalario Universitario de A Coruña; 🇪🇸 A Coruña, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Universitario Virgen de la Victoria; 🇪🇸 Málaga, Spain

Hospital Clínico Universitario de Valladolid; 🇪🇸 Valladolid, Spain