Hyperglycaemia (Non Diabetic)GlyENStrokeNCT03422900
Hyperglycemia in Patients with Stroke and Indication of Enteral Nutrition
A study testing Diabetes-Specific enteral formula and Standard formula in people with Hyperglycaemia (Non Diabetic) and Enteral Feeding Intolerance, run by Endocrinology and Clinical Nutrition Research Center, Spain at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperglycaemia (Non Diabetic), Enteral Feeding Intolerance, Stroke
- What is being tested?
- Diabetes-Specific enteral formula and Standard formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSpain
- Study dates
- 12 Dec 2017to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted for a first episode of ischemic or hemorrhagic stroke.
- Requiring total enteral nutrition by tube for at least 7 days
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Two Enteral Nutrition Formulas on Hyperglycemia and Morbidity in Patients with Stroke
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.
Read the 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.
- Being tested
- Diabetes-Specific enteral formula, Standard formula
- Medical subject headings
- Hyperglycemia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes-Specific enteral formulaDietary supplement
Also called DIABA
Complete enteral formula normocaloric hyperproteic with fiber (80% SOLUBLE)
Standard formulaDietary supplement
Also called Fresubin Original
Complete enteral formula normocaloric hormoproteic without fiber
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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 Receives: Dietary Supplement: Standard formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 WEEKS
Secondary outcomes (2)
MORTALITY
Mortality during study period. Dicotomic variable (Yes/No)
Measured: 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)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start12 Dec 2017
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hyperglycaemia (Non Diabetic)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endocrinology and Clinical Nutrition Research Center, Spain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel de Luis Roman, Endocrinology and Clinical Nutrition Research Center, Spain
- Investigators
- Daniel A De Luis Román, Prof. Dr., Study director, Service of Endocrinology and Nutrition. Clinic Hospital University of ValladolidJuan J López-Gómez, Prof. Dr., Principal investigator, Service of Endocrinology and Nutrition. Clinic Hospital University of ValladolidJavier F Arenillas-Lara, Prof. Dr., Study chair, Service of Neurology. Clinic Hospital University of Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03422900
- Sponsor's protocol ID
- CASVE-NM-17-315
- Acronym
- GlyENStroke
- Status last verified
- Sep 2023
- First submitted
- 10 Dec 2017
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38816400
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Two Enteral Nutrition Formulas on Hyperglycemia and Morbidity in Patients with Stroke
- ClinicalTrials.gov ID
- NCT03422900
- Acronym / sponsor ID
- GlyENStroke / CASVE-NM-17-315
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Endocrinology and Clinical Nutrition Research Center, SpainUniversity, hospital or other
- Study start
- 12 Dec 2017 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 6 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Specific Diabetes Formula | Experimental | Dietary Supplement: Diabetes-Specific enteral formulaDiabetes-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 Formula | Active comparator | Dietary Supplement: Standard formulaStandard 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Admitted for a first episode of ischemic or hemorrhagic stroke.
- Requiring total enteral nutrition by tube for at least 7 days
Key exclusion criteria (8 listed)
- Contraindication to enteral nutrition
- Diabetes Mellitus
- Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting, abdominal pain
- Need for admission to the ICU
- Previous neurodegenerative disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diabetes-Specific enteral formulaAlso: DIABAComplete enteral formula normocaloric hyperproteic with fiber (80% SOLUBLE) | Dietary supplement | Specific Diabetes Formula |
| Standard formulaAlso: Fresubin OriginalComplete enteral formula normocaloric hormoproteic without fiber | Dietary supplement | Standard Formula |
Primary outcome
HYPERGLUCEMIA POST-ENTERAL NUTRITION
Time frame: 2 WEEKS
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 secondary outcomes
MORTALITY
Time frame: 3 months
ORAL FEEDING RECOVERY
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 38816400Lopez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel A De Luis Román, Prof. Dr. study director
Service of Endocrinology and Nutrition. Clinic Hospital University of Valladolid
Juan J López-Gómez, Prof. Dr. principal investigator
Service of Endocrinology and Nutrition. Clinic Hospital University of Valladolid
Javier F Arenillas-Lara, Prof. Dr. study chair
Service of Neurology. Clinic Hospital University of Valladolid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes-Specific enteral formula and Standard formula in people with Hyperglycaemia (Non Diabetic) and Enteral Feeding Intolerance, run by Endocrinology and Clinical Nutrition Research Center, Spain at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HYPERGLUCEMIA POST-ENTERAL NUTRITION (time frame: 2 WEEKS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03422900, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.