Hyperglycemia in Patients With Stroke and Indication of Enteral Nutrition

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Influence of Two Enteral Nutrition Formulas on Hyperglycemia and Morbidity in Patients With Stroke

Conditions
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Stroke, Hyperglycaemia (Non Diabetic), Enteral Feeding Intolerance

Intervention / Treatment
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* Dietary Supplement: Diabetes-Specific enteral formula
* Dietary Supplement: Standard formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admitted for a first episode of ischemic or hemorrhagic stroke. Requiring total enteral nutrition by tube for at least 7 days Exclusion Criteria: Contraindication to enteral nutrition 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Comparison of two formulas of enteral nutrition (diabetes-specific enteral formula (lower glycemic index and presence of soluble and insoluble fiber) compared to an standard formula (isocaloric and isonitrogenated formula without fiber)) in patients without diabetes mellitus admitted due to stroke and with indication of nutritional support by nasogastric tube
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Specific Diabetes Formula<br>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<br>* Complete enteral formula normocaloric hyperproteic with fiber (80% SOLUBLE)<br>* Other names: DIABA;|
| Active Comparator: Standard Formula<br>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<br>* Complete enteral formula normocaloric hormoproteic without fiber<br>* Other names: Fresubin Original;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 2 WEEKS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MORTALITY | Mortality during study period. Dicotomic variable (Yes/No) | 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) | 3 months |