Hyperglycemia in Patients With Stroke and Indication of Enteral Nutrition

Stroke Clinical Trial

— GlyENStroke  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03422900
• Other study ID #: CASVE-NM-17-315
• Status: Recruiting
• Phase: N/A
• First received: December 10, 2017
• Last updated: January 30, 2018
• Start date: December 12, 2017
• Est. completion date: December 15, 2020

Study information

• Verified date: January 2018
• Source: Endocrinology and Clinical Nutrition Research Center, Spain
• Contact: Juan J López-Gómez, Prof. Dr.
• Phone: 983420000
• Email: jjlopez161282[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 15, 2020
• Est. primary completion date: June 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enteral Feeding Intolerance
• Hyperglycaemia (Non Diabetic)
• Hyperglycemia
• Stroke

Intervention

Dietary Supplement:
• Diabetes-Specific enteral formula
Complete enteral formula normocaloric hyperproteic with fiber (80% SOLUBLE)
• Standard formula
Complete enteral formula normocaloric hormoproteic without fiber

Locations

Country	Name	City	State
Spain	Clinic Universitary Hospital	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
Endocrinology and Clinical Nutrition Research Center, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	MORTALITY	Mortality during study period. Dicotomic variable (Yes/No)	3 months
Secondary	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