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NCT Number: NCT03422900

Hyperglycemia in Patients with Stroke and Indication of Enteral Nutrition

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.

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Key information

Conditions

Hyperglycaemia (Non Diabetic) Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Enteral Feeding Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinic Universitary Hospital

Valladolid, 47003, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diabetes-Specific enteral formula

Dietary Supplement

Complete enteral formula normocaloric hyperproteic with fiber (80% SOLUBLE)

Other names: DIABA

Standard formula

Dietary Supplement

Complete enteral formula normocaloric hormoproteic without fiber

Other names: Fresubin Original

Primary outcomes

  1. HYPERGLUCEMIA POST-ENTERAL NUTRITION

    Time frame: 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 outcomes

  1. MORTALITY

    Time frame: 3 months

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

  2. ORAL FEEDING RECOVERY

    Time frame: 3 months

    Recovery of oral feeding (More than 75% of energy needs) and withdrawal of nasogastric tube during admission. Dicotomic variable (Yes/No)

Sponsors and collaborators

Lead sponsor

Endocrinology and Clinical Nutrition Research Center, Spain

Other

Registry information

Official study title

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

Acronym: GlyENStroke

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Feb 6, 2018
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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