Hyperglycemia in Patients with Stroke and Indication of Enteral Nutrition
NCT ID: NCT03422900
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
52 participants
INTERVENTIONAL
2017-12-12
2021-09-30
Brief Summary
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Detailed Description
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To evaluate the effect on the development of hyperglycemia diagnosed as glycemia\> 126 mg / dl on an empty stomach or\> 150 mg / dl during the infusion of enteral nutrition determined by capillary glycemia during the admission of a specific formula in patients with a first episode of ischemic stroke or hemorrhagic entry into the non-diabetic HCUV stroke unit requiring enteral nutrition by nasogastric tube.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Specific Diabetes Formula
Diabetes-Specific Enteral Formula:
* Caloric density: 1,0 kcal/ml
* Energy: 100 kcal
* Carbohydrates: 10,1 g/100 ml;
* Fat: 4,5 g/100 ml
* Prot: 3,8 g/100 ml
* Osmolarity: 345 mOsm/l
* Fiber: 1,78 g/100 ml (80% soluble; 20% insoluble).
Diabetes-Specific enteral formula
Complete enteral formula normocaloric hyperproteic with fiber (80% SOLUBLE)
Standard Formula
Standard Enteral Formula:
* Caloric density: 1,0 kcal/ml
* Energy: 100 kcal
* Carbohydrates: 13,8 g/100 ml;
* Fat: 3,4 g/100 ml
* Prot: 3,8 g/100 ml
* Osmolarity: 220 mOsm/l
* Fiber: 0 g/100 ml
Standard formula
Complete enteral formula normocaloric hormoproteic without fiber
Interventions
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Diabetes-Specific enteral formula
Complete enteral formula normocaloric hyperproteic with fiber (80% SOLUBLE)
Standard formula
Complete enteral formula normocaloric hormoproteic without fiber
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Requiring total enteral nutrition by tube for at least 7 days
Exclusion Criteria
* Diabetes Mellitus
* Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting, abdominal pain
* Need for admission to the ICU
* Previous neurodegenerative disease
* Antibiotherapy for 7 days prior to the inclusion visit
* Allergies or intolerances to any of the components of the formula under study
* Pregnant patients
18 Years
ALL
No
Sponsors
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Endocrinology and Clinical Nutrition Research Center, Spain
OTHER
Responsible Party
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Daniel de Luis Roman
Profesor Doctor
Principal Investigators
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Daniel A De Luis Román, Prof. Dr.
Role: STUDY_DIRECTOR
Service of Endocrinology and Nutrition. Clinic Hospital University of Valladolid
Juan J López-Gómez, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Service of Endocrinology and Nutrition. Clinic Hospital University of Valladolid
Javier F Arenillas-Lara, Prof. Dr.
Role: STUDY_CHAIR
Service of Neurology. Clinic Hospital University of Valladolid
Locations
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Clinic Universitary Hospital
Valladolid, Valladolid, Spain
Countries
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References
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Lopez-Gomez JJ, Delgado Garcia E, Primo-Martin D, Simon de la Fuente M, Gomez-Hoyos E, Jimenez-Sahagun R, Torres-Torres B, Ortola-Buigues A, Gomez-Vicente B, Arenillas-Lara JF, De Luis Roman DA. Effect of a diabetes-specific formula in non-diabetic inpatients with stroke: a randomized controlled trial. Nutr Diabetes. 2024 May 30;14(1):34. doi: 10.1038/s41387-024-00292-4.
Other Identifiers
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CASVE-NM-17-315
Identifier Type: -
Identifier Source: org_study_id
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