MalnutritionNCT06031766
Comparison of CIPA With the GLIM Criteria and Prevalence of Sarcopenia in Inpatients
An observational study of Malnutrition, run by University Hospital of the Nuestra Señora de Candelaria at 1 site in Spain.
Trial summary
Determine the diagnostic quality of the CIPA tool, in inpatients with stays longer than three days, in the observation of risk of malnutrition compared to the gold standard GLIM as a diagnosis of malnutrition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- Dietary supplement
- How many people
- 490 participants
- Where
- 1 siteSpain
- Study dates
- 7 Jan 2022to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult subjects of both sexes with a hospital stay of more than three days.
Who may be able to join
- Adult subjects (> 18 years old).
- Hospital stay more than 3 days.
- Admitted to one of the following departments: general surgery, internal medicine, vascular surgery, digestive system, hematology, nephrology, pulmonology, oncology, neurology, traumatology.
Who cannot join
- Subjects with a prognosis of hospital stay less or equal than 3 days.
- Admitted to services with a low incidence of malnutrition: ophthalmology, dermatology or obstetrics.
- Admitted or critical care unit and palliative care.
- Pediatric patient.
- Patients treated with nutritional support before CIPA screening is performed.
- Patients with edema-ascitic overload.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
UniversityHNSC
Santa Cruz de Tenerife, 38010
Elena Márquez Mesa, Physician, 697232171 ext. +34, elenamqz@hotmail.com
About this study
Official title: Comparison of CIPA With the GLIM Criteria of Malnutrition and Prevalence of Sarcopenia in Inpatients
Determine the diagnostic quality of the CIPA tool, in inpatients with stays longer than three days, in the observation of risk of malnutrition compared to the gold standard GLIM as a diagnosis of malnutrition.
Read the detailed description
Background: malnutrition is a poor prognostic factor in inpatients. Its early detection, together to nutritional intervention, can improve clinical evolution. It is important to carry out nutritional screening, however, there is no gold standard, and CIPA (Control of Intakes, Proteins and Anthropometry) has been implemented in our setting. The GLIM criteria (Global Leadership Initiative on Malnutrition) aim to provide a global consensus that allows common criteria for malnutrition diagnosis. The objective of this study is to evaluate the diagnostic quality of the CIPA screening vs the GLIM criteria for malnutrition as well as to establish the prevalence of sarcopenia.
Methods: cross-sectional single-center study comparing the diagnostic quality of CIPA in the diagnosis of malnutrition or risk of presenting it in inpatients vs GLIM. Adults of both sexes with a hospital stay of more than three days and attached to one of the following departments will be included: general surgery, internal medicine, vascular surgery, digestive system, hematology, nephrology, pulmonology, oncology, neurology, traumatology. The diagnostic evaluation of malnutrition and functionality will be carried out after three days of hospital stay, once the CIPA screening has been carried out. The participation of the patients in the study will consist of performing the CIPA malnutrition screening to which the GLIM test will be added. For the CIPA test, the BMI (body mass index), albumin levels and percentage of decreased intake will be taken. For the GLIM test, phenotypic criteria such as non-voluntary weight loss and reduction in muscle mass will also be studied together with etiological criteria to which, in addition to those referred to for the CIPA test, the presence of inflammation will be added. The study consists of a first cross-sectional part that will be completed once the data of the 490 subjects selected through probabilistic sampling has been collected. The second part of the study will consist of the prospective follow-up of the patients and the variables will be analyzed with prognostic criteria.
Discussion: this study will evaluate the diagnostic quality of CIPA vs the GLIM criteria for malnutrition and will establish the prevalence of sarcopenia in inpatients.
- Conditions
- Malnutrition
- Being tested
- Dietary supplement
- Keywords
- GLIM criteria, CIPA, phase angle, hospital stay, mortality, body composition, screening, Sarcopenia, inpatient, nutrition assessment
- Medical subject headings
- Malnutrition, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary supplementDietary supplement
The participation of the patients in the study will consist of performing the screening for malnutrition that is usually used in the hospital (CIPA) to which the GLIM test will be added, considered as the gold standard for this work. Subsequently, the sample of patients with a positive CIPA (as it is currently considered the screening test used in the hospital) will be implemented the therapeutic measures according to the usual protocol, while the subjects with a negative CIPA test but a positive GLIM will be studied. and constant monitoring taking the appropriate measures according to optional criteria. The patients will be followed up for the study of prognostic factors based on the variables obtained.
What is being measured
The primary outcome is the main question the study is designed to answer.
The concordance between CIPA test and the GLIM criteria determined by the Kappa coefficient.
Measured: 6 months
Secondary outcomes (3)
Incidence of mortality
Measured: 6 months
Mean length of stay (days)
Measured: 6 months
Incidence of readmissions
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start7 Jan 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 490 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of the Nuestra Señora de Candelaria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Marquez Mesa, University Hospital of the Nuestra Señora de Candelaria
- Investigators
- Elena Márquez Mesa, Physician, Principal investigator, University HNSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06031766
- Sponsor's protocol ID
- UniversityHNSC
- Status last verified
- Sep 2023
- First submitted
- 20 Aug 2023
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gomes F, Baumgartner A, Bounoure L, Bally M, Deutz NE, Greenwald JL, Stanga Z, Mueller B, Schuetz P. Association of Nutritional Support With Clinical Outcomes Among Medical Inpatients Who Are Malnourished or at Nutritional Risk: An Updated Systematic Review and Meta-analysis. JAMA Netw Open. 2019 Nov 1;2(11):e1915138. doi: 10.1001/jamanetworkopen.2019.15138.
PubMed 31747030Alvarez-Hernandez J, Planas Vila M, Leon-Sanz M, Garcia de Lorenzo A, Celaya-Perez S, Garcia-Lorda P, Araujo K, Sarto Guerri B; PREDyCES researchers. Prevalence and costs of malnutrition in hospitalized patients; the PREDyCES Study. Nutr Hosp. 2012 Jul-Aug;27(4):1049-59. doi: 10.3305/nh.2012.27.4.5986.
PubMed 23165541Zugasti Murillo A, Petrina-Jauregui ME, Ripa-Ciaurriz C, Sanchez Sanchez R, Villazon-Gonzalez F, Gonzalez-Diaz Faes A, Fernandez-Lopez C, Calles-Romero L, Martin Palmero MA, Riestra-Fernandez M, Dublang-Irazabal M, Rengel-Jimenez J, Diez-Muniz-Alique M, Agorreta-Ruiz JJ, Salsamendi-Perez JL, Larranaga-Unanue I, Abinzano-Guillen ML, Olariaga O, De la Cruz JJ. SeDREno study - prevalence of hospital malnutrition according to GLIM criteria, ten years after the PREDyCES study. Nutr Hosp. 2021 Oct 13;38(5):1016-1025. doi: 10.20960/nh.03638.
PubMed 34157845Mora Mendoza A, Suarez Llanos JP, Sanchez Morales A, Lorenzo Gonzalez C, Zambrano Huerta Y, Llorente Gomez de Segura I. Validation of CIPA nutritional screening through prognostic clinical variables in hospitalized surgical patients. Endocrinol Diabetes Nutr (Engl Ed). 2020 May;67(5):304-309. doi: 10.1016/j.endinu.2019.07.008. Epub 2019 Oct 24. English, Spanish.
PubMed 31668927Suarez Llanos JP, Benitez Brito N, Oliva Garcia JG, Pereyra-Garcia Castro F, Lopez Frias MA, Garcia Hernandez A, Diaz Sirgo B, Llorente Gomez de Segura I. [Introducing a mixed nutritional screening tool (CIPA) in a tertiary hospital]. Nutr Hosp. 2014 May 1;29(5):1149-53. doi: 10.3305/nh.2014.29.5.7299. Spanish.
PubMed 24951997Mendoza AM, Suarez Llanos JP, Delgado Brito I, Pereyra-Garcia Castro F, Lopez Travieso R, Perez Delgado N, Garcia Nunez MA, Benitez Brito N, Palacio Abizanda E. [Optimisation of nutritional screening tool CIPA: are two parameters of protein really necessary?]. Nutr Hosp. 2018 Aug 2;35(4):914-919. doi: 10.20960/nh.1701. Spanish.
PubMed 30070882Suarez-Llanos JP, Mora-Mendoza A, Benitez-Brito N, Perez-Mendez L, Pereyra-Garcia-Castro F, Oliva-Garcia JG, Palacio-Abizanda JE. Validity of the new nutrition screening tool Control of Food Intake, Protein, and Anthropometry (CIPA) in non-surgical inpatients. Arch Med Sci. 2018 Aug;14(5):1020-1024. doi: 10.5114/aoms.2017.66084. Epub 2017 Feb 20.
PubMed 30154883Suarez-Llanos JP, Vallejo-Torres L, Garcia-Bello MA, Hernandez-Carballo C, Calderon-Ledezma EM, Rosat-Rodrigo A, Delgado-Brito I, Pereyra-Garcia-Castro F, Benitez-Brito N, Felipe-Perez N, Ramallo-Farina Y, Romero-Perez JC. Cost-effectiveness of the hospital nutrition screening tool CIPA. Arch Med Sci. 2019 Jan 11;16(2):273-281. doi: 10.5114/aoms.2018.81128. eCollection 2020.
PubMed 32190136Suarez-Llanos JP, Benitez-Brito N, Vallejo-Torres L, Delgado-Brito I, Rosat-Rodrigo A, Hernandez-Carballo C, Ramallo-Farina Y, Pereyra-Garcia-Castro F, Carlos-Romero J, Felipe-Perez N, Garcia-Niebla J, Calderon-Ledezma EM, Gonzalez-Melian TJ, Llorente-Gomez de Segura I, Barrera-Gomez MA. Clinical and cost-effectiveness analysis of early detection of patients at nutrition risk during their hospital stay through the new screening method CIPA: a study protocol. BMC Health Serv Res. 2017 Apr 20;17(1):292. doi: 10.1186/s12913-017-2218-z.
PubMed 28424063Cederholm T, Jensen GL, Correia MITD, Gonzalez MC, Fukushima R, Higashiguchi T, Baptista G, Barazzoni R, Blaauw R, Coats A, Crivelli A, Evans DC, Gramlich L, Fuchs-Tarlovsky V, Keller H, Llido L, Malone A, Mogensen KM, Morley JE, Muscaritoli M, Nyulasi I, Pirlich M, Pisprasert V, de van der Schueren MAE, Siltharm S, Singer P, Tappenden K, Velasco N, Waitzberg D, Yamwong P, Yu J, Van Gossum A, Compher C; GLIM Core Leadership Committee; GLIM Working Group. GLIM criteria for the diagnosis of malnutrition - A consensus report from the global clinical nutrition community. Clin Nutr. 2019 Feb;38(1):1-9. doi: 10.1016/j.clnu.2018.08.002. Epub 2018 Sep 3.
PubMed 30181091Correia MITD, Tappenden KA, Malone A, Prado CM, Evans DC, Sauer AC, Hegazi R, Gramlich L. Utilization and validation of the Global Leadership Initiative on Malnutrition (GLIM): A scoping review. Clin Nutr. 2022 Mar;41(3):687-697. doi: 10.1016/j.clnu.2022.01.018. Epub 2022 Feb 1.
PubMed 35151125Garlini LM, Alves FD, Ceretta LB, Perry IS, Souza GC, Clausell NO. Phase angle and mortality: a systematic review. Eur J Clin Nutr. 2019 Apr;73(4):495-508. doi: 10.1038/s41430-018-0159-1. Epub 2018 Apr 26.
PubMed 29695763Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jul 1;48(4):601. doi: 10.1093/ageing/afz046. No abstract available.
PubMed 31081853Boulhosa RSSB, Lourenco RP, Cortes DM, Oliveira LPM, Lyra AC, de Jesus RP. Comparison between criteria for diagnosing malnutrition in patients with advanced chronic liver disease: GLIM group proposal versus different nutritional screening tools. J Hum Nutr Diet. 2020 Dec;33(6):862-868. doi: 10.1111/jhn.12759. Epub 2020 May 7.
PubMed 32378264Clark AB, Reijnierse EM, Lim WK, Maier AB. Prevalence of malnutrition comparing the GLIM criteria, ESPEN definition and MST malnutrition risk in geriatric rehabilitation patients: RESORT. Clin Nutr. 2020 Nov;39(11):3504-3511. doi: 10.1016/j.clnu.2020.03.015. Epub 2020 Mar 23.
PubMed 32273200
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of CIPA With the GLIM Criteria of Malnutrition and Prevalence of Sarcopenia in Inpatients
- ClinicalTrials.gov ID
- NCT06031766
- Acronym / sponsor ID
- UniversityHNSC
- Conditions
- Malnutrition
- Keywords
- GLIM criteria, CIPA, phase angle, hospital stay, mortality, body composition, screening, Sarcopenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 490 participants (estimated)
- Lead sponsor
- University Hospital of the Nuestra Señora de CandelariaUniversity, hospital or other
- Study start
- 7 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 11 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine the diagnostic quality of the CIPA tool, in inpatients with stays longer than three days, in the observation of risk of malnutrition compared to the gold standard GLIM as a diagnosis of malnutrition.
Detailed description
Background: malnutrition is a poor prognostic factor in inpatients. Its early detection, together to nutritional intervention, can improve clinical evolution. It is important to carry out nutritional screening, however, there is no gold standard, and CIPA (Control of Intakes, Proteins and Anthropometry) has been implemented in our setting. The GLIM criteria (Global Leadership Initiative on Malnutrition) aim to provide a global consensus that allows common criteria for malnutrition diagnosis. The objective of this study is to evaluate the diagnostic quality of the CIPA screening vs the GLIM criteria for malnutrition as well as to establish the prevalence of sarcopenia.
Methods: cross-sectional single-center study comparing the diagnostic quality of CIPA in the diagnosis of malnutrition or risk of presenting it in inpatients vs GLIM. Adults of both sexes with a hospital stay of more than three days and attached to one of the following departments will be included: general surgery, internal medicine, vascular surgery, digestive system, hematology, nephrology, pulmonology, oncology, neurology, traumatology. The diagnostic evaluation of malnutrition and functionality will be carried out after three days of hospital stay, once the CIPA screening has been carried out. The participation of the patients in the study will consist of performing the CIPA malnutrition screening to which the GLIM test will be added. For the CIPA test, the BMI (body mass index), albumin levels and percentage of decreased intake will be taken. For the GLIM test, phenotypic criteria such as non-voluntary weight loss and reduction in muscle mass will also be studied together with etiological criteria to which, in addition to those referred to for the CIPA test, the presence of inflammation will be added. The study consists of a first cross-sectional part that will be completed once the data of the 490 subjects selected through probabilistic sampling has been collected. The second part of the study will consist of the prospective follow-up of the patients and the variables will be analyzed with prognostic criteria.
Discussion: this study will evaluate the diagnostic quality of CIPA vs the GLIM criteria for malnutrition and will establish the prevalence of sarcopenia in inpatients.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects of both sexes with a hospital stay of more than three days.
Key inclusion criteria (3 listed)
- Adult subjects (> 18 years old).
- Hospital stay more than 3 days.
- Admitted to one of the following departments: general surgery, internal medicine, vascular surgery, digestive system, hematology, nephrology, pulmonology, oncology, neurology, traumatology.
Key exclusion criteria (6 listed)
- Subjects with a prognosis of hospital stay less or equal than 3 days.
- Admitted to services with a low incidence of malnutrition: ophthalmology, dermatology or obstetrics.
- Admitted or critical care unit and palliative care.
- Pediatric patient.
- Patients treated with nutritional support before CIPA screening is performed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary supplementThe participation of the patients in the study will consist of performing the screening for malnutrition that is usually used in the hospital (CIPA) to which the GLIM test will be added, considered as the gold standard for this work. Subsequently, the sample of patients with a positive CIPA (as it is currently considered the screening test used in the hospital) will be implemented the therapeutic measures according to the usual protocol, while the subjects with a negative CIPA test but a positive GLIM will be studied. and constant monitoring taking the appropriate measures according to optional criteria. The patients will be followed up for the study of prognostic factors based on the variables obtained. | Dietary supplement | – |
Primary outcome
The concordance between CIPA test and the GLIM criteria determined by the Kappa coefficient.
Time frame: 6 months
3 secondary outcomes
Incidence of mortality
Time frame: 6 months
Mean length of stay (days)
Time frame: 6 months
Incidence of readmissions
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Results publication: PubMed 31747030Gomes F, Baumgartner A, Bounoure L, Bally M, Deutz NE, Greenwald JL, Stanga Z, Mueller B, Schuetz P. Association of Nutritional Support With Clinical Outcomes Among Medical Inpatients Who Are Malnourished or at Nutritional Risk: An Updated Systematic Review and Meta-analysis. JAMA Netw Open. 2019 Nov 1;2(11):e1915138. doi: 10.1001/jamanetworkopen.2019.15138.
- Results publication: PubMed 23165541Alvarez-Hernandez J, Planas Vila M, Leon-Sanz M, Garcia de Lorenzo A, Celaya-Perez S, Garcia-Lorda P, Araujo K, Sarto Guerri B; PREDyCES researchers. Prevalence and costs of malnutrition in hospitalized patients; the PREDyCES Study. Nutr Hosp. 2012 Jul-Aug;27(4):1049-59. doi: 10.3305/nh.2012.27.4.5986.
- Results publication: PubMed 34157845Zugasti Murillo A, Petrina-Jauregui ME, Ripa-Ciaurriz C, Sanchez Sanchez R, Villazon-Gonzalez F, Gonzalez-Diaz Faes A, Fernandez-Lopez C, Calles-Romero L, Martin Palmero MA, Riestra-Fernandez M, Dublang-Irazabal M, Rengel-Jimenez J, Diez-Muniz-Alique M, Agorreta-Ruiz JJ, Salsamendi-Perez JL, Larranaga-Unanue I, Abinzano-Guillen ML, Olariaga O, De la Cruz JJ. SeDREno study - prevalence of hospital malnutrition according to GLIM criteria, ten years after the PREDyCES study. Nutr Hosp. 2021 Oct 13;38(5):1016-1025. doi: 10.20960/nh.03638.
- Results publication: PubMed 31668927Mora Mendoza A, Suarez Llanos JP, Sanchez Morales A, Lorenzo Gonzalez C, Zambrano Huerta Y, Llorente Gomez de Segura I. Validation of CIPA nutritional screening through prognostic clinical variables in hospitalized surgical patients. Endocrinol Diabetes Nutr (Engl Ed). 2020 May;67(5):304-309. doi: 10.1016/j.endinu.2019.07.008. Epub 2019 Oct 24. English, Spanish.
- Results publication: PubMed 24951997Suarez Llanos JP, Benitez Brito N, Oliva Garcia JG, Pereyra-Garcia Castro F, Lopez Frias MA, Garcia Hernandez A, Diaz Sirgo B, Llorente Gomez de Segura I. [Introducing a mixed nutritional screening tool (CIPA) in a tertiary hospital]. Nutr Hosp. 2014 May 1;29(5):1149-53. doi: 10.3305/nh.2014.29.5.7299. Spanish.
- Results publication: PubMed 30070882Mendoza AM, Suarez Llanos JP, Delgado Brito I, Pereyra-Garcia Castro F, Lopez Travieso R, Perez Delgado N, Garcia Nunez MA, Benitez Brito N, Palacio Abizanda E. [Optimisation of nutritional screening tool CIPA: are two parameters of protein really necessary?]. Nutr Hosp. 2018 Aug 2;35(4):914-919. doi: 10.20960/nh.1701. Spanish.
- Results publication: PubMed 30154883Suarez-Llanos JP, Mora-Mendoza A, Benitez-Brito N, Perez-Mendez L, Pereyra-Garcia-Castro F, Oliva-Garcia JG, Palacio-Abizanda JE. Validity of the new nutrition screening tool Control of Food Intake, Protein, and Anthropometry (CIPA) in non-surgical inpatients. Arch Med Sci. 2018 Aug;14(5):1020-1024. doi: 10.5114/aoms.2017.66084. Epub 2017 Feb 20.
- Results publication: PubMed 32190136Suarez-Llanos JP, Vallejo-Torres L, Garcia-Bello MA, Hernandez-Carballo C, Calderon-Ledezma EM, Rosat-Rodrigo A, Delgado-Brito I, Pereyra-Garcia-Castro F, Benitez-Brito N, Felipe-Perez N, Ramallo-Farina Y, Romero-Perez JC. Cost-effectiveness of the hospital nutrition screening tool CIPA. Arch Med Sci. 2019 Jan 11;16(2):273-281. doi: 10.5114/aoms.2018.81128. eCollection 2020.
- Results publication: PubMed 28424063Suarez-Llanos JP, Benitez-Brito N, Vallejo-Torres L, Delgado-Brito I, Rosat-Rodrigo A, Hernandez-Carballo C, Ramallo-Farina Y, Pereyra-Garcia-Castro F, Carlos-Romero J, Felipe-Perez N, Garcia-Niebla J, Calderon-Ledezma EM, Gonzalez-Melian TJ, Llorente-Gomez de Segura I, Barrera-Gomez MA. Clinical and cost-effectiveness analysis of early detection of patients at nutrition risk during their hospital stay through the new screening method CIPA: a study protocol. BMC Health Serv Res. 2017 Apr 20;17(1):292. doi: 10.1186/s12913-017-2218-z.
- Results publication: PubMed 30181091Cederholm T, Jensen GL, Correia MITD, Gonzalez MC, Fukushima R, Higashiguchi T, Baptista G, Barazzoni R, Blaauw R, Coats A, Crivelli A, Evans DC, Gramlich L, Fuchs-Tarlovsky V, Keller H, Llido L, Malone A, Mogensen KM, Morley JE, Muscaritoli M, Nyulasi I, Pirlich M, Pisprasert V, de van der Schueren MAE, Siltharm S, Singer P, Tappenden K, Velasco N, Waitzberg D, Yamwong P, Yu J, Van Gossum A, Compher C; GLIM Core Leadership Committee; GLIM Working Group. GLIM criteria for the diagnosis of malnutrition - A consensus report from the global clinical nutrition community. Clin Nutr. 2019 Feb;38(1):1-9. doi: 10.1016/j.clnu.2018.08.002. Epub 2018 Sep 3.
- Results publication: PubMed 35151125Correia MITD, Tappenden KA, Malone A, Prado CM, Evans DC, Sauer AC, Hegazi R, Gramlich L. Utilization and validation of the Global Leadership Initiative on Malnutrition (GLIM): A scoping review. Clin Nutr. 2022 Mar;41(3):687-697. doi: 10.1016/j.clnu.2022.01.018. Epub 2022 Feb 1.
- Results publication: PubMed 29695763Garlini LM, Alves FD, Ceretta LB, Perry IS, Souza GC, Clausell NO. Phase angle and mortality: a systematic review. Eur J Clin Nutr. 2019 Apr;73(4):495-508. doi: 10.1038/s41430-018-0159-1. Epub 2018 Apr 26.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Márquez Mesa, Physician principal investigator
University HNSC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition, run by University Hospital of the Nuestra Señora de Candelaria at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elena Márquez Mesa, Physician (697232171 ext. +34, elenamqz@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The concordance between CIPA test and the GLIM criteria determined by the Kappa coefficient. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06031766, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023.