Critical IllnessNCT01233726

Effects of a Complete Diet in Critically Ill Patients With Stress Hyperglycemia

A study testing T-Diet plus Diabet IR, ISOSOURCE PROTEIN FIBRE and GLUCERNA SELECT in people with Critical Illness and Hyperglycemia, run by Vegenat, S.A. at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of the study is to evaluate the beneficial effects of the administration of a complete diet rich in monounsaturated fatty acids (MUFA) and slow absorption carbohydrate in patients with stress hyperglycemia(T-Diet Plus Diabet IR). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Critical Illness, Hyperglycemia, Dietary Modification
What is being tested?: T-Diet plus Diabet IR, ISOSOURCE PROTEIN FIBRE and GLUCERNA SELECT
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 159 participants
Where: 2 sitesSpain
Study dates: Apr 2010to Feb 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Patients over 18 admitted to intensive care units (ICU), with mechanical ventilation.
Patients receiving EN (enteral nutrition), for 5 days or more.
ICU stay in 48 hours or less, in the time of study inclusion.
Patients developing hyperglycemia in 48 hours of stay in ICU.
Nutritional support initiation within 48 hours of stay in ICU.

Who cannot join

Patients with a life expectancy less than 48 hours.
Patients participating in another study.
Patients with APACHE II (Acute Physiology and Chronic Health Evaluation) less than 10.
Patients with BMI (body mass index) > 40 Kg/m2.
Patients with Type I Diabetes.
Patients on chronic treatment with corticosteroid dose above 1 mg / kg / day of methylprednisolone or equivalent.

Show all 19Show fewer

Pregnant patients.
Patients taking lipid-lowering drugs.
Acute renal failure patients, defined by the following criteria:
Serum creatinine greater than 4 mg / dL with acute rise higher than 0.5 mg / dl / day.
Serum creatinine higher than 3 mg/dL.
Diuresis < 0.3 ml/kg/h during 24 hours.
Anury for 12 hours or more.
Hepatic failure patients, defined by the following parameters:
Serious acute hepatic failure.
Child degrees B-C.
Serum bilirubin higher than 3 mg/dL.
Patients with parenteral nutrition during study inclusion.
Informed consent absence.

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

Intensive Care Unit. Hospital Universitario 12 de Octubre
Madrid, Madrid
Intensive Care Unit. Hospital Clinico Universitario de Valencia
Valencia, Valencia

Other trials in Spain

About this study

Official title: Effects of a Complete Diet Rich in Monounsaturated Fatty Acids and Slow Absorption Carbohydrate Administration in Critically Ill Patients With Stress Hyperglycemia. Open Study, Blind Randomised, Multicenter and Controlled.

The main objective of this project is to evaluate blood glucose metabolic control, insulin requirements, insulin action resistance, lipid profile and to reduce infectious complications on mechanical ventilation ICU (intensive care unit) patients after the administration of a complete diet enriched in MUFA and slow absorption carbohydrates, without fructose.

Read the detailed description

Enteral formula administration designed for critically ill patients in metabolic stress situations, hyperglycemia and insulin resistance, formulated with monounsaturated fatty acids (MUFA), slowly absorption carbohydrates, omega-3 series polyunsaturated fatty acids (PUFA)enriched in eicosapentanoic acid (EPA) and docosahexaenoic acid (DHA), should be associated with an improvement in metabolic control, based on glucose levels reduction, and a decrease of insulin resistance infectious complications , mechanical ventilation days, ICU and hospital stay. All this against other two high protein conventional specific diets for hyperglycaemia patients.

Conditions: Critical Illness, Hyperglycemia, Dietary Modification, Metabolic Stress Hyperglycemia, Mechanical Ventilation Complication
Being tested: T-Diet plus Diabet IR, ISOSOURCE PROTEIN FIBRE, GLUCERNA SELECT
Keywords: Critical illness, Hyperglycemia, Mechanical Ventilation, Enteral nutrition, T-Diet plus Diabet IR, Malnutrition, Insulin resistance, Metabolic stress
Medical subject headings: Critical Illness, Hyperglycemia, Malnutrition, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

T-Diet plus Diabet IRDietary supplement
Also called DIABA HP
Group 1 will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric.
ISOSOURCE PROTEIN FIBREDietary supplement
Also called ISS PROT FIB
Group 2 will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric.
GLUCERNA SELECTDietary supplement
Also called GLUC SEL
Group 3 will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric.

Study groups in NCT01233726
Study group	Role	What they receive
T-DIET PLUS DIABET IR	Experimental	Patients of this group will receive T-Diet plus Diabet IR as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric Receives: Dietary Supplement: T-Diet plus Diabet IR
ISOSOURCE PROTEIN FIBRE	Active comparator	Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric Receives: Dietary Supplement: ISOSOURCE PROTEIN FIBRE
GLUCERNA SELECT	Active comparator	Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric Receives: Dietary Supplement: GLUCERNA SELECT

What is being measured

The primary outcome is the main question the study is designed to answer.

Measure of Biochemical Parameters and Evaluation of Infectious Complications 1
The variables recorded related to glycemic control in mg/dL are provided in this table.
Measured: 28 days post-admission
Measure of Biochemical Parameters and Evaluation of Infectious Complications 2
The variables recorded related to administered insulin in IU/day are provided in this table
Measured: 28 days post-admission
Measure of Biochemical Parameters and Evaluation of Infectious Complications 3
The variables recorded related to number of capillary glycemia measurements are provided in this table
Measured: 28 days post-admission
Measure of Biochemical Parameters and Evaluation of Infectious Complications 4
The variables recorded related to the number of measurements per patient per day are provided in this table
Measured: 28 days post-admission
Measure of Biochemical Parameters and Evaluation of Infectious Complications 5
The variables recorded related to Glycemic CV (%) are provided in this table:
- Glycemic Coeficient of variation (%) after 28 days in ICU
- Glycemic Coeficient of variation (%) after 7 days in ICU.
Measured: 28 days post-admission
Primary Outcome: Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.1
This table shows the number of capillary glycemia measurements
Measured: 28 days post-admission
Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.2
This table shows the rates of:
- Controls analysis on 80-150 mg/dL: optimal level of glycemia rate.
- Hypoglycemia (50-80 mg/dL): moderate hypoglycemia rate.
- Hypoglycemia (<50 mg/dL): severe hypoglycemia episodes rate.
Measured: 28 days post-admission

Secondary outcomes (4)

Assessment of Critical Ill Patients Progress During Hospital Stay 1
Infectious complication incidence rate per 100 days of treatment are provided in this table.
Measured: 100 days of treatment
Assessment of Critical Ill Patients Progress During Hospital Stay 2
Number of participants with catheter-associated bloodstream infection, primary bloodstream infection or urinary tract infection are provided in this table
Measured: 28 days post-admission
Assessment of Critical Ill Patients Progress During Hospital Stay 3
The incidence of tracheobronchitis and ventilator-associated pneumonia per 1000 days of mechanical ventilation are provided in this table.
Measured: 28 days post-admission
Assessment of Critical Ill Patients Progress During Hospital Stay 4
Number of participants with infectious complications is provided in this table.
Measured: 100 days of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2010Feb 2015

First posted3 Nov 2010 (estimated)
Study startApr 2010
Primary completionFeb 2015
Study completionFeb 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Critical IllnessStudies 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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 159 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01233726
Sponsor's protocol ID: IR2009
Other IDs: DIABET IR IDI-20080283
Status last verified: Jul 2016
First submitted: 29 Oct 2010
Last updated: 1 Sep 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided

Publications

Mesejo A, Montejo-Gonzalez JC, Vaquerizo-Alonso C, Lobo-Tamer G, Zabarte-Martinez M, Herrero-Meseguer JI, Acosta-Escribano J, Blesa-Malpica A, Martinez-Lozano F. Diabetes-specific enteral nutrition formula in hyperglycemic, mechanically ventilated, critically ill patients: a prospective, open-label, blind-randomized, multicenter study. Crit Care. 2015 Nov 9;19:390. doi: 10.1186/s13054-015-1108-1.
PubMed 26549276

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of a Complete Diet Rich in Monounsaturated Fatty Acids and Slow Absorption Carbohydrate Administration in Critically Ill Patients With Stress Hyperglycemia. Open Study, Blind Randomised, Multicenter and Controlled.
ClinicalTrials.gov ID: NCT01233726
Acronym / sponsor ID: IR2009
Conditions: Critical Illness, Hyperglycemia, Dietary Modification, Metabolic Stress Hyperglycemia, Mechanical Ventilation Complication
Keywords: Critical illness, Hyperglycemia, Mechanical Ventilation, Enteral nutrition, T-Diet plus Diabet IR, Malnutrition, Insulin resistance, Metabolic stress
Study type: Interventional
Recruitment status: Completed
Enrolment: 159 participants (actual)
Lead sponsor: Vegenat, S.A.Industry (pharma, biotech, devices)
Study start: Apr 2010
Primary completion: Feb 2015 (actual)
Study completion: Feb 2015 (actual)
First posted: 3 Nov 2010 (estimated)
Results: Posted 1 Sep 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
T-DIET PLUS DIABET IR	Experimental	Dietary Supplement: T-Diet plus Diabet IRPatients of this group will receive T-Diet plus Diabet IR as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric
ISOSOURCE PROTEIN FIBRE	Active comparator	Dietary Supplement: ISOSOURCE PROTEIN FIBREPatients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric
GLUCERNA SELECT	Active comparator	Dietary Supplement: GLUCERNA SELECTPatients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Patients over 18 admitted to intensive care units (ICU), with mechanical ventilation.
Patients receiving EN (enteral nutrition), for 5 days or more.
ICU stay in 48 hours or less, in the time of study inclusion.
Patients developing hyperglycemia in 48 hours of stay in ICU.
Nutritional support initiation within 48 hours of stay in ICU.

Key exclusion criteria (19 listed)

Patients with a life expectancy less than 48 hours.
Patients participating in another study.
Patients with APACHE II (Acute Physiology and Chronic Health Evaluation) less than 10.
Patients with BMI (body mass index) > 40 Kg/m2.
Patients with Type I Diabetes.

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
T-Diet plus Diabet IRAlso: DIABA HPGroup 1 will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric.	Dietary supplement	T-DIET PLUS DIABET IR
ISOSOURCE PROTEIN FIBREAlso: ISS PROT FIBGroup 2 will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric.	Dietary supplement	ISOSOURCE PROTEIN FIBRE
GLUCERNA SELECTAlso: GLUC SELGroup 3 will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric.	Dietary supplement	GLUCERNA SELECT

Primary outcome

Measure of Biochemical Parameters and Evaluation of Infectious Complications 1
Time frame: 28 days post-admission
The variables recorded related to glycemic control in mg/dL are provided in this table.
Measure of Biochemical Parameters and Evaluation of Infectious Complications 2
Time frame: 28 days post-admission
The variables recorded related to administered insulin in IU/day are provided in this table
Measure of Biochemical Parameters and Evaluation of Infectious Complications 3
Time frame: 28 days post-admission
The variables recorded related to number of capillary glycemia measurements are provided in this table
Measure of Biochemical Parameters and Evaluation of Infectious Complications 4
Time frame: 28 days post-admission
The variables recorded related to the number of measurements per patient per day are provided in this table
Measure of Biochemical Parameters and Evaluation of Infectious Complications 5
Time frame: 28 days post-admission
The variables recorded related to Glycemic CV (%) are provided in this table: * Glycemic Coeficient of variation (%) after 28 days in ICU * Glycemic Coeficient of variation (%) after 7 days in ICU.
Primary Outcome: Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.1
Time frame: 28 days post-admission
This table shows the number of capillary glycemia measurements
Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.2
Time frame: 28 days post-admission
This table shows the rates of: * Controls analysis on 80-150 mg/dL: optimal level of glycemia rate. * Hypoglycemia (50-80 mg/dL): moderate hypoglycemia rate. * Hypoglycemia (<50 mg/dL): severe hypoglycemia episodes rate.

4 secondary outcomes

Assessment of Critical Ill Patients Progress During Hospital Stay 1
Time frame: 100 days of treatment
Assessment of Critical Ill Patients Progress During Hospital Stay 2
Time frame: 28 days post-admission
Assessment of Critical Ill Patients Progress During Hospital Stay 3
Time frame: 28 days post-admission
Assessment of Critical Ill Patients Progress During Hospital Stay 4
Time frame: 100 days of treatment

Results and safety

Results posted to the registry on 1 Sep 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DIABA HP	53	52
ISOSOURCE PROTEIN FIBRE	53	53
GLUCERNA SELECT	53	52

Primary outcome: Measure of Biochemical Parameters and Evaluation of Infectious Complications 1

Time frame: 28 days post-admission. Mean (Standard Deviation). Unit: mg/dL

Measure	Diaba HP n = 52	ISOSOURCE PROTEIN FIBRE n = 53	GLUCERNA SELECT n = 52
Plasma glucose level (mg/dL)	138.6 (39.1)	146.1 (49.9)	143.9 (45.9)
Capillary glucose level (mg/dL)	146.1 (45.8)	155.3 (63.6)	150.1 (41.9)
Mean capillary glycemia on ICU day 1 (mg/dL)	147.5 (40.2)	160 (55.5)	145.6 (46.6)
Peak glucose level (mg/dL)	181.3 (52)	193.6 (74.6)	191.3 (65.8)
Glycemic variability SD (mg/dL) (ICU days 1-28)	33.6 (18.4)	49.1 (21.5)	41.1 (9.3)
Glycemic variability SD (mg/dL) (ICU days 1-7)	43.2 (4.9)	68.5 (13.5)	42.5 (2.7)

Population analysed: Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose \>126 mg/dL after fasting or\>200 mg/dL otherwise) in the first 48 h of ICU admission.

Primary outcome: Measure of Biochemical Parameters and Evaluation of Infectious Complications 2

Time frame: 28 days post-admission. Mean (Standard Deviation). Unit: IU/day

Measure	Diaba HP n = 52	ISOSOURCE PROTEIN FIBRE n = 53	GLUCERNA SELECT n = 52
Value	19.1 (13.1)	23.7 (40.1)	20.3 (30.1)

Primary outcome: Measure of Biochemical Parameters and Evaluation of Infectious Complications 3

Time frame: 28 days post-admission. Number. Unit: Capillary glycemia measurements

Measure	Diaba HP n = 52	ISOSOURCE PROTEIN FIBRE n = 53	GLUCERNA SELECT n = 52
Value	3605	3523	3557

Primary outcome: Measure of Biochemical Parameters and Evaluation of Infectious Complications 4

Time frame: 28 days post-admission. Mean (Standard Deviation). Unit: Measurements per patient/day

Measure	Diaba HP n = 52	ISOSOURCE PROTEIN FIBRE n = 53	GLUCERNA SELECT n = 52
Value	5.7 (3.4)	5.81 (3.2)	5.46 (2.9)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: All participants were followed at the ICU for a maximum of 28 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DIABA HP	0 of 52 (0%)	0 of 52 (0%)	Not reported
ISOSOURCE PROTEIN FIBRE	0 of 53 (0%)	0 of 53 (0%)	Not reported
GLUCERNA SELECT	0 of 52 (0%)	0 of 52 (0%)	Not reported

Limitations and caveats (from the sponsor): No overall limitations and caveats have been observed and/or registered related with the products intake during the clinical trial period.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26549276Mesejo A, Montejo-Gonzalez JC, Vaquerizo-Alonso C, Lobo-Tamer G, Zabarte-Martinez M, Herrero-Meseguer JI, Acosta-Escribano J, Blesa-Malpica A, Martinez-Lozano F. Diabetes-specific enteral nutrition formula in hyperglycemic, mechanically ventilated, critically ill patients: a prospective, open-label, blind-randomized, multicenter study. Crit Care. 2015 Nov 9;19:390. doi: 10.1186/s13054-015-1108-1.
Individual participant dataSharing planned: Undecided

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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.

Alfonso Mesejo, PhD principal investigator

Hospital Clinico Universitario de Valencia

Juan Carlos Montejo, PhD principal investigator

Hospital Universitario 12 de Octubre

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing T-Diet plus Diabet IR, ISOSOURCE PROTEIN FIBRE and GLUCERNA SELECT in people with Critical Illness and Hyperglycemia, run by Vegenat, S.A. at 2 sites 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 5 inclusion and 19 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 1 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Yes. Results are posted in the registry (first posted 1 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Measure of Biochemical Parameters and Evaluation of Infectious Complications 1 (time frame: 28 days post-admission). The study lists 7 primary outcomes in all. 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 NCT01233726, 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 1 Sep 2016.