NCT01233726

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
159

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

April 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 3, 2010

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

September 1, 2016

Completed
Last Updated

September 1, 2016

Status Verified

July 1, 2016

Enrollment Period

4.8 years

First QC Date

October 29, 2010

Results QC Date

December 18, 2015

Last Update Submit

July 20, 2016

Conditions

Critical IllnessHyperglycemiaDietary ModificationMetabolic Stress HyperglycemiaMechanical Ventilation Complication

Keywords

Critical illnessHyperglycemiaMechanical VentilationEnteral nutritionT-Diet plus Diabet IRMalnutritionInsulin resistanceMetabolic stress

Outcome Measures

Primary Outcomes (7)

  • 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.

    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

    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

    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

    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.

    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

    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.

    28 days post-admission

Secondary Outcomes (4)

  • Assessment of Critical Ill Patients Progress During Hospital Stay 1

    100 days of treatment

  • Assessment of Critical Ill Patients Progress During Hospital Stay 2

    28 days post-admission

  • Assessment of Critical Ill Patients Progress During Hospital Stay 3

    28 days post-admission

  • Assessment of Critical Ill Patients Progress During Hospital Stay 4

    100 days of treatment

Study Arms (3)

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

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

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

Dietary Supplement: GLUCERNA SELECT

Interventions

T-Diet plus Diabet IRDIETARY_SUPPLEMENT

Group 1 will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric.

Also known as: DIABA HP
T-DIET PLUS DIABET IR
ISOSOURCE PROTEIN FIBREDIETARY_SUPPLEMENT

Group 2 will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric.

Also known as: ISS PROT FIB
ISOSOURCE PROTEIN FIBRE
GLUCERNA SELECTDIETARY_SUPPLEMENT

Group 3 will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric.

Also known as: GLUC SEL
GLUCERNA SELECT

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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.
  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Intensive Care Unit. Hospital Universitario 12 de Octubre

Madrid, Madrid, Spain

Location

Intensive Care Unit. Hospital Clinico Universitario de Valencia

Valencia, Valencia, Spain

Location

Related Publications (1)

  • 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.

    PMID: 26549276DERIVED

MeSH Terms

Conditions

Critical IllnessHyperglycemiaMalnutritionInsulin Resistance

Interventions

Phentermine

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesNutrition DisordersHyperinsulinism

Intervention Hierarchy (Ancestors)

AmphetaminesPhenethylaminesEthylaminesAminesOrganic Chemicals

Limitations and Caveats

No overall limitations and caveats have been observed and/or registered related with the products intake during the clinical trial period.

Results Point of Contact

Title
Alfonso Mesejo
Organization
Intensive Care Unit, Hospital Clínico Universitario
mesejo_alf@gva.es
961 97 35 00

Study Officials

  • Alfonso Mesejo, PhD

    Hospital Clinico Universitario de Valencia

    PRINCIPAL INVESTIGATOR

  • Juan Carlos Montejo, PhD

    Hospital Universitario 12 de Octubre

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2010

First Posted

November 3, 2010

Study Start

April 1, 2010

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

September 1, 2016

Results First Posted

September 1, 2016

Record last verified: 2016-07

Locations

ES(2)