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GlyENStroke: Hyperglycemia in Patients With Stroke and Indication of Enteral Nutrition

Sponsor
Endocrinology and Clinical Nutrition Research Center, Spain (Other)
Overall Status
Unknown status
CT.gov ID
NCT03422900
Collaborator
(none)
150
Enrollment
1
Location
2
Arms
36.1
Anticipated Duration (Months)
4.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Diabetes-Specific enteral formula
  • Dietary Supplement: Standard formula
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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 tubeComparison 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
Masking:
Double (Participant, Care Provider)
Masking Description:
cover label
Primary Purpose:
Treatment
Official Title:
Influence of Two Enteral Nutrition Formulas on Hyperglycemia and Morbidity in Patients With Stroke
Actual Study Start Date :
Dec 12, 2017
Anticipated Primary Completion Date :
Jun 15, 2019
Anticipated Study Completion Date :
Dec 15, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. MORTALITY [3 months]

      Mortality during study period. Dicotomic variable (Yes/No)

    2. 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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinic Universitary Hospital Valladolid Spain 47003

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Daniel de Luis Roman, Profesor Doctor, Endocrinology and Clinical Nutrition Research Center, Spain
    ClinicalTrials.gov Identifier:
    NCT03422900
    Other Study ID Numbers:
    • CASVE-NM-17-315
    First Posted:
    Feb 6, 2018
    Last Update Posted:
    Feb 6, 2018
    Last Verified:
    Jan 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Stroke
    Hyperglycemia

    Study Results

    No Results Posted as of Feb 6, 2018