Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Specific Diabetes Formula | Experimental | Diabetes-Specific Enteral Formula:
|
|
| Standard Formula | Active Comparator | Standard Enteral Formula:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diabetes-Specific enteral formula | Dietary Supplement | Complete enteral formula normocaloric hyperproteic with fiber (80% SOLUBLE) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| MORTALITY | Mortality during study period. Dicotomic variable (Yes/No) | 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Daniel A De Luis Román, Prof. Dr. | Service of Endocrinology and Nutrition. Clinic Hospital University of Valladolid | Study Director |
| Juan J López-Gómez, Prof. Dr. | Service of Endocrinology and Nutrition. Clinic Hospital University of Valladolid | Principal Investigator |
| Javier F Arenillas-Lara, Prof. Dr. | Service of Neurology. Clinic Hospital University of Valladolid | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic Universitary Hospital | Valladolid | Valladolid | 47003 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38816400 | Derived | Lopez-Gomez JJ, Delgado Garcia E, Primo-Martin D, Simon de la Fuente M, Gomez-Hoyos E, Jimenez-Sahagun R, Torres-Torres B, Ortola-Buigues A, Gomez-Vicente B, Arenillas-Lara JF, De Luis Roman DA. Effect of a diabetes-specific formula in non-diabetic inpatients with stroke: a randomized controlled trial. Nutr Diabetes. 2024 May 30;14(1):34. doi: 10.1038/s41387-024-00292-4. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D002561 | Cerebrovascular Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C058870 | (4-(4,5-dihydro-1H-imidazol-2-yl)amino)benzoic acid |
Not provided
Not provided
Not provided
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
Not provided
Not provided
cover label
| Standard formula | Dietary Supplement | Complete enteral formula normocaloric hormoproteic without fiber |
|
|
| 3 months |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |