An interventional study of Diabetes-Specific enteral formula and Standard formula in Hyperglycaemia (Non Diabetic), Enteral Feeding Intolerance and Stroke, sponsored by Endocrinology and Clinical Nutrition Research Center, Spain. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Endocrinology and Clinical Nutrition Research Center, Spain · Not applicable, Interventional, and Treatment
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.
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.
800 studies on the registry are indexed under Hyperglycemia; 115 are open to participants now.
This study's enrollment of 52 is close to the median of 50 across 620 interventional studies indexed under Hyperglycemia.
Browse Hyperglycemia studies →Endocrinology and Clinical Nutrition Research Center, Spain is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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 hyperproteic with fiber (80% SOLUBLE)
Also known as: DIABA
Complete enteral formula normocaloric hormoproteic without fiber
Also known as: Fresubin Original
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)
Time frame: 2 WEEKS
MORTALITY
Mortality during study period. Dicotomic variable (Yes/No)
Time frame: 3 months
ORAL FEEDING RECOVERY
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
Plan to share: No
No publications or documents are linked to this record.
Ran from Dec 2017 to primary completion in Sep 2021, 45 months.
Of 208 non-industry interventional studies with no phase under Hyperglycemia, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 27. This study's 45 months is above that.
Counting every sponsor, half of 225 studies reached it within 14 months; a quarter within 7 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Endocrinology and Clinical Nutrition Research Center, Spain