Hyperglycaemia (Non Diabetic), Enteral Feeding Intolerance, Stroke
Conditions
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTDiabetes-Specific enteral formula
Complete enteral formula normocaloric hyperproteic with fiber (80% SOLUBLE)
DIETARY_SUPPLEMENTStandard formula
Complete enteral formula normocaloric hormoproteic without fiber
Sponsors
Endocrinology and Clinical Nutrition Research Center, Spain
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
cover label
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HYPERGLUCEMIA POST-ENTERAL NUTRITION | 2 WEEKS | Glycemia over 150 mg / dl after the beginning of infusion of complete enteral. nutrition determined by capillary glycemia during admission. Dicotomic variable (Yes/No) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MORTALITY | 3 months | Mortality during study period. Dicotomic variable (Yes/No) |
| ORAL FEEDING RECOVERY | 3 months | Recovery of oral feeding (More than 75% of energy needs) and withdrawal of nasogastric tube during admission. Dicotomic variable (Yes/No) |
Countries
Spain
Outcome results
None listed