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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03422900
Other study ID # CASVE-NM-17-315
Secondary ID
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
Health authority
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

Study Design


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
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