Clinical trial NCT03422900: Hyperglycemia in Patients with Stroke and Indication of Enteral Nutrition
Official title: Influence of Two Enteral Nutrition Formulas on Hyperglycemia and Morbidity in Patients with Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperglycaemia (Non Diabetic)
Enteral Feeding Intolerance
Stroke
Lead sponsor: Endocrinology and Clinical Nutrition Research Center, Spain
Sponsor class: OTHER
First posted: 2018-02-06
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: HYPERGLUCEMIA POST-ENTERAL NUTRITION
timeFrame: 2 WEEKS
Secondary outcomes:
measure: MORTALITY
timeFrame: 3 months
measure: ORAL FEEDING RECOVERY
timeFrame: 3 months
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: Clinic Universitary Hospital
Study officials:
affiliation: Service of Endocrinology and Nutrition. Clinic Hospital University of Valladolid
name: Daniel A De Luis Román, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Service of Endocrinology and Nutrition. Clinic Hospital University of Valladolid
name: Juan J López-Gómez, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Service of Neurology. Clinic Hospital University of Valladolid
name: Javier F Arenillas-Lara, Prof. Dr.
role: STUDY_CHAIR
References: