An observational study in Disease-related Malnutrition and Inflammation, sponsored by Endocrinology and Clinical Nutrition Research Center, Spain. Completed at 15 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Endocrinology and Clinical Nutrition Research Center, Spain · Observational
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.
3,536 studies on the registry are indexed under Inflammation; 642 are open to participants now.
This study's enrollment of 271 is above the median of 100 across 864 observational studies indexed under Inflammation.
Browse Inflammation studies →Endocrinology and Clinical Nutrition Research Center, Spain is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with a diagnosis of DRM with the presence of an inflammatory response (CRP>3 mg/dl).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Nutritional intervention with an oral nutrition supplement with anti-inflammatory effect and a programme of physical exercise
Also known as: Physical activity
Blood biochemistry data
Albumin (g/dL)
Time frame: Patients will be followed over a period of 3 consecutive months
Blood biochemistry data
Prealbumin (mg/dL)
Time frame: Patients will be followed over a period of 3 consecutive months
Blood biochemistry data
C-reactive protein (mg/L)
Time frame: Patients will be followed over a period of 3 consecutive months
Blood biochemistry data
Ferritin (ng/mL)
Time frame: Patients will be followed over a period of 3 consecutive months
Blood biochemistry data
Neutrophils (x103/μL)
Time frame: Patients will be followed over a period of 3 consecutive months
Blood biochemistry data
Lymphocytes (x103/μL)
Time frame: Patients will be followed over a period of 3 consecutive months
Blood biochemistry data
Platelets (x103/μL)
Time frame: Patients will be followed over a period of 3 consecutive months
Bioelectrical impedance data (model (50 kHz)
TBW (total body water, L)
Time frame: Patients will be followed over a period of 3 consecutive months
Bioelectrical impedance data (model (50 kHz)
ECW (extracellular water, L)
Time frame: Patients will be followed over a period of 3 consecutive months
Bioelectrical impedance data (model (50 kHz)
ICW (intracellular water, L)
Time frame: Patients will be followed over a period of 3 consecutive months
Bioelectrical impedance data (model (50 kHz)
FFM (lean mass, kg)
Time frame: Patients will be followed over a period of 3 consecutive months
Bioelectrical impedance data (model (50 kHz)
FM (fat mass, kg)
Time frame: Patients will be followed over a period of 3 consecutive months
Bioelectrical impedance data (model (50 kHz)
BCM (body cell mass, kg)
Time frame: Patients will be followed over a period of 3 consecutive months
Bioelectrical impedance data (model (50 kHz)
ASMM (appendicular skeletal muscle mass, kg)
Time frame: Patients will be followed over a period of 3 consecutive months
Bioelectrical impedance data (model (50 kHz)
SMI (skeletal muscle mass index, kg)
Time frame: Patients will be followed over a period of 3 consecutive months
Functional parameters
Test up and go (patient sits in a chair and is told to stand up (time starts), walks 3 meters, comes back and sits down (time ends). \<20 seconds: OK; \>20seconds: increased risk of falling
Time frame: Patients will be followed over a period of 3 consecutive months
Functional parameters
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
Time frame: Patients will be followed over a period of 3 consecutive months
Oral intake
Energy: obtained from the nutritional analysis of a two-day dietary survey using the programme https://calcdieta.ienva.org (kcal)
Time frame: Patients will be followed over a period of 3 consecutive months
Oral intake
Protein: obtained from the nutritional analysis of a two-day dietary survey using the programme https://calcdieta.ienva.org (g)
Time frame: Patients will be followed over a period of 3 consecutive months
Oral intake
Carbohydrate: obtained from the nutritional analysis of a two-day dietary survey using the programme https://calcdieta.ienva.org (g)
Time frame: Patients will be followed over a period of 3 consecutive months
Oral intake
Fat: obtained from the nutritional analysis of a two-day dietary survey using the programme https://calcdieta.ienva.org (g)
Time frame: Patients will be followed over a period of 3 consecutive months
Oral intake
MUFA (monounsaturated fat acids): obtained from the nutritional analysis of a two-day dietary survey using the programme https://calcdieta.ienva.org (g)
Time frame: Patients will be followed over a period of 3 consecutive months
Oral intake
PUFA (polyunsaturated fat acids): obtained from the nutritional analysis of a two-day dietary survey using the programme https://calcdieta.ienva.org (g)
Time frame: Patients will be followed over a period of 3 consecutive months
Oral intake
EPA: obtained from the nutritional analysis of a two-day dietary survey using the programme https://calcdieta.ienva.org (mg)
Time frame: Patients will be followed over a period of 3 consecutive months
Oral intake
DHA: obtained from the nutritional analysis of a two-day dietary survey using the programme https://calcdieta.ienva.org (mg)
Time frame: Patients will be followed over a period of 3 consecutive months
Oral intake
Fibre: obtained from the nutritional analysis of a two-day dietary survey using the programme https://calcdieta.ienva.org (g)
Time frame: Patients will be followed over a period of 3 consecutive months
Malnutrition Diagnosis
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
Time frame: Patients will be followed over a period of 3 consecutive months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Endocrinology and Clinical Nutrition Research Center, Spain