An interventional study of Diabetes-Specific enteral formula and Standard formula in Hyperglycaemia (Non Diabetic), Enteral Feeding Intolerance and Stroke, sponsored by Endocrinology and Clinical Nutrition Research Center, Spain. Completed at 1 site 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 · Not applicable, Interventional, and Treatment
The purpose of this study is to evaluate the effect of a specific nutritional formula for diabetics on the development of hyperglycemia in patients with recent non-diabetic stroke who require admission and enteral nutritional support by nasogastric tube. As well as the effect on metabolic control, development of comorbidities, hospital stay, readmissions, mortality and tolerance of the formula under study.
MAIN GOAL:
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.
Exclusion Criteria:
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).
Dietary Supplement: Diabetes-Specific enteral 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
Dietary Supplement: Standard formula
Complete enteral formula normocaloric hyperproteic with fiber (80% SOLUBLE)
Also known as: DIABA
Complete enteral formula normocaloric hormoproteic without fiber
Also known as: Fresubin Original
HYPERGLUCEMIA POST-ENTERAL NUTRITION
Glycemia over 150 mg / dl after the beginning of infusion of complete enteral. nutrition determined by capillary glycemia during admission. Dicotomic variable (Yes/No)
Time frame: 2 WEEKS
MORTALITY
Mortality during study period. Dicotomic variable (Yes/No)
Time frame: 3 months
ORAL FEEDING RECOVERY
Recovery of oral feeding (More than 75% of energy needs) and withdrawal of nasogastric tube during admission. Dicotomic variable (Yes/No)
Time frame: 3 months
Plan to share: No
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Endocrinology and Clinical Nutrition Research Center, Spain