Hyperglycemia in Patients with Stroke and Indication of Enteral Nutrition (GlyENStroke)

Endocrinology and Clinical Nutrition Research Center, Spain

Status: Completed

Conditions: Stroke; Hyperglycaemia (Non Diabetic); Enteral Feeding Intolerance

Treatments: Dietary Supplement: Standard formula; Dietary Supplement: Diabetes-Specific enteral formula

Study type: Interventional

Funder types: Other

Identifiers

NCT03422900

CASVE-NM-17-315

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

52 participants in 2 patient groups

Specific Diabetes Formula

Experimental group

Description:

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).

Treatment:

Dietary Supplement: Diabetes-Specific enteral formula

Standard Formula

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Standard formula