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

Primary Purpose

Hyperglycaemia (Non Diabetic), Enteral Feeding Intolerance, Stroke

Status

Unknown status

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Diabetes-Specific enteral formula

Standard formula

About this trial

This is an interventional treatment trial for Hyperglycaemia (Non Diabetic)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Clinic Universitary HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Specific Diabetes Formula

Standard Formula

Arm 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).

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

MORTALITY

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

ORAL FEEDING RECOVERY

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

Full Information

NCT ID

NCT03422900

First Posted

December 10, 2017

Last Updated

January 30, 2018

Sponsor

Endocrinology and Clinical Nutrition Research Center, Spain

1. Study Identification

Unique Protocol Identification Number

NCT03422900

Brief Title

Hyperglycemia in Patients With Stroke and Indication of Enteral Nutrition

Acronym

GlyENStroke

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Unknown status

Study Start Date

December 12, 2017 (Actual)

Primary Completion Date

June 15, 2019 (Anticipated)

Study Completion Date

December 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Endocrinology and Clinical Nutrition Research Center, Spain

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperglycaemia (Non Diabetic), Enteral Feeding Intolerance, Stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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 tube

Masking

ParticipantCare Provider

Masking Description

cover label

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Specific Diabetes Formula

Arm Type

Experimental

Arm Description

Arm Title

Standard Formula

Arm Type

Active Comparator

Arm 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

Intervention Type

Dietary Supplement

Intervention Name(s)

Diabetes-Specific enteral formula

Other Intervention Name(s)

DIABA

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Standard formula

Other Intervention Name(s)

Fresubin Original

Intervention Description

Complete enteral formula normocaloric hormoproteic without fiber

Primary Outcome Measure Information:

Title

HYPERGLUCEMIA POST-ENTERAL NUTRITION

Description

Glycemia over 150 mg / dl after the beginning of infusion of complete enteral. nutrition determined by capillary glycemia during admission. Dicotomic variable (Yes/No)

Time Frame

2 WEEKS

Secondary Outcome Measure Information:

Title

MORTALITY

Description

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

Time Frame

3 months

Title

ORAL FEEDING RECOVERY

Description

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

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Juan J López-Gómez, Prof. Dr.

Phone

983420000

Ext

86158

jjlopez161282@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Daniel A De Luis-Román, Prof. Dr.

Phone

983420000

Ext

86660

dadluis@yahoo.es

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel A De Luis Román, Prof. Dr.

Organizational Affiliation

Service of Endocrinology and Nutrition. Clinic Hospital University of Valladolid

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Juan J López-Gómez, Prof. Dr.

Organizational Affiliation

Service of Endocrinology and Nutrition. Clinic Hospital University of Valladolid

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Javier F Arenillas-Lara, Prof. Dr.

Organizational Affiliation

Service of Neurology. Clinic Hospital University of Valladolid

Official's Role

Study Chair

Facility Information:

Facility Name

Clinic Universitary Hospital

City

Valladolid

ZIP/Postal Code

47003

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Juan J López-Gómez, Prof. Dr.

Phone

983420000

Ext

86158

jjlopez161282@hotmail.com

First Name & Middle Initial & Last Name & Degree

Daniel A De Luis-Román, Prof. Dr.

Phone

983420000

Ext

86660

dadluis@yahoo.es

First Name & Middle Initial & Last Name & Degree

Daniel A De Luis-Román, Prof. Dr.

First Name & Middle Initial & Last Name & Degree

Juan J López-Gómez, Prof. Dr.

First Name & Middle Initial & Last Name & Degree

Javier F Arenillas-Lara, Prof. Dr.

First Name & Middle Initial & Last Name & Degree

Esther Delgado-García, Dra.

First Name & Middle Initial & Last Name & Degree

Emilia Gómez-Hoyos, Dra.

First Name & Middle Initial & Last Name & Degree

Ana Ortolá-Buigues, Dra.

First Name & Middle Initial & Last Name & Degree

Beatriz Torres-Torres, Dra.

First Name & Middle Initial & Last Name & Degree

Ana Calleja-Sanz, Dra.

First Name & Middle Initial & Last Name & Degree

Elisa Cortijo-García, Dra.

First Name & Middle Initial & Last Name & Degree

Mercedes De Lera, Dra.

First Name & Middle Initial & Last Name & Degree

Ángeles Castro-Lozano, Dipl.

First Name & Middle Initial & Last Name & Degree

Silvia Rodríguez-Gómez, Dipl.

First Name & Middle Initial & Last Name & Degree

Lourdes De Marcos-White, Dipl.

First Name & Middle Initial & Last Name & Degree

Beatriz Gómez-Vicente, Dipl.

First Name & Middle Initial & Last Name & Degree

Pedro L Muñoz-Rubio, Dipl

First Name & Middle Initial & Last Name & Degree

Javier Reyes-Muñoz, Dipl

First Name & Middle Initial & Last Name & Degree

Rosa Alcaide-Flores, Dipl

First Name & Middle Initial & Last Name & Degree

Ana Martín, Dipl

12. IPD Sharing Statement

Plan to Share IPD

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Hyperglycemia in Patients With Stroke and Indication of Enteral Nutrition

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