Hyperglycemia in Patients With Stroke and Indication of Enteral Nutrition

Not Applicable

• Conditions: Enteral Feeding Intolerance; Hyperglycaemia (Non Diabetic); Stroke
• Interventions: Dietary Supplement: Diabetes-Specific enteral formula; Dietary Supplement: Standard formula

• Registration Number: NCT03422900
• Lead Sponsor: Endocrinology and Clinical Nutrition Research Center, Spain

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.

Study Timeline

• Study First Submitted: 2017-12-10
• Study Start: 2017-12-12
• Status Verified: 2018-01
• Study First Submitted QC: 2018-01-30
• Last Update Submitted: 2018-01-30
• Study First Posted: 2018-02-06
• Last Update Posted: 2018-02-06
• Primary Completion: 2019-06-15
• Study Completion: 2020-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Specific Diabetes Formula	Diabetes-Specific enteral 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).
Standard Formula	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Clinic Universitary Hospital; 🇪🇸 Valladolid, Spain