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

Influence of Two Enteral Nutrition Formulas on Hyperglycemia and Morbidity in Patients with Stroke

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Enteral Feeding Intolerance; Hyperglycaemia (Non Diabetic)
• Intervention / Treatment: Dietary supplement: Diabetes-Specific enteral formula; Dietary supplement: Standard formula

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valladolid, Spain, 47003
    • Clinic Universitary Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Specific Diabetes 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).	Dietary supplement: Diabetes-Specific enteral formula; Complete enteral formula normocaloric hyperproteic with fiber (80% SOLUBLE); Other Names: DIABA
Active Comparator: 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	Dietary supplement: Standard formula; Complete enteral formula normocaloric hormoproteic without fiber; Other Names: Fresubin Original

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Endocrinology and Clinical Nutrition Research Center, Spain
• Investigators: Study Director: Daniel A De Luis Román, Prof. Dr., Service of Endocrinology and Nutrition. Clinic Hospital University of Valladolid; Principal Investigator: Juan J López-Gómez, Prof. Dr., Service of Endocrinology and Nutrition. Clinic Hospital University of Valladolid; Study Chair: Javier F Arenillas-Lara, Prof. Dr., Service of Neurology. Clinic Hospital University of Valladolid

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2017
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: December 10, 2017
• First Submitted That Met QC Criteria: January 30, 2018
• First Posted (Actual): February 6, 2018

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 11, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hyperglycemia; Stroke
• Other Study ID Numbers: CASVE-NM-17-315

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No