NCT03422900

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

December 12, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 6, 2018

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2023

Enrollment Period

3.8 years

First QC Date

December 10, 2017

Last Update Submit

September 11, 2024

Conditions

Hyperglycaemia (Non Diabetic)Enteral Feeding IntoleranceStroke

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • MORTALITY

    3 months

  • ORAL FEEDING RECOVERY

    3 months

Study Arms (2)

Specific Diabetes Formula

EXPERIMENTAL

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 Formula

ACTIVE COMPARATOR

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

Interventions

Diabetes-Specific enteral formulaDIETARY_SUPPLEMENT

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

Also known as: DIABA
Specific Diabetes Formula
Standard formulaDIETARY_SUPPLEMENT

Complete enteral formula normocaloric hormoproteic without fiber

Also known as: Fresubin Original
Standard Formula

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Admitted for a first episode of ischemic or hemorrhagic stroke.
  • Requiring total enteral nutrition by tube for at least 7 days

You may not qualify if:

  • Contraindication to enteral nutrition
  • Diabetes Mellitus
  • Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting, abdominal pain
  • Need for admission to the ICU
  • Previous neurodegenerative disease
  • Allergies or intolerances to any of the components of the formula under study
  • Pregnant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic Universitary Hospital

Valladolid, Valladolid, 47003, Spain

Location

Related Publications (1)

  • 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.

    PMID: 38816400DERIVED

MeSH Terms

Conditions

HyperglycemiaStroke

Interventions

(4-(4,5-dihydro-1H-imidazol-2-yl)amino)benzoic acid

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
cover label
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Profesor Doctor

Study Record Dates

First Submitted

December 10, 2017

First Posted

February 6, 2018

Study Start

December 12, 2017

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

September 19, 2024

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)