Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vegenat, S.A.
ClinicalTrials.gov Identifier:
NCT01233726
First received: October 29, 2010
Last updated: July 20, 2016
Last verified: July 2016
  Purpose

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.


Condition Intervention
Critical Illness
Hyperglycemia
Dietary Modification
Metabolic Stress Hyperglycemia
Mechanical Ventilation Complication
Dietary Supplement: T-Diet plus Diabet IR
Dietary Supplement: ISOSOURCE PROTEIN FIBRE
Dietary Supplement: GLUCERNA SELECT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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.

Resource links provided by NLM:


Further study details as provided by Vegenat, S.A.:

Primary Outcome Measures:
  • Measure of Biochemical Parameters and Evaluation of Infectious Complications 1 [ Time Frame: 28 days post-admission ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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.


Secondary Outcome Measures:
  • Assessment of Critical Ill Patients Progress During Hospital Stay 1 [ Time Frame: 100 days of treatment ] [ Designated as safety issue: No ]
    Infectious complication incidence rate per 100 days of treatment are provided in this table.

  • Assessment of Critical Ill Patients Progress During Hospital Stay 2 [ Time Frame: 28 days post-admission ] [ Designated as safety issue: No ]
    Number of participants with catheter-associated bloodstream infection, primary bloodstream infection or urinary tract infection are provided in this table

  • Assessment of Critical Ill Patients Progress During Hospital Stay 3 [ Time Frame: 28 days post-admission ] [ Designated as safety issue: No ]
    The incidence of tracheobronchitis and ventilator-associated pneumonia per 1000 days of mechanical ventilation are provided in this table.

  • Assessment of Critical Ill Patients Progress During Hospital Stay 4 [ Time Frame: 100 days of treatment ] [ Designated as safety issue: No ]
    Number of participants with infectious complications is provided in this table.


Enrollment: 159
Study Start Date: April 2010
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: T-DIET PLUS DIABET IR
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
Group 1 will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric.
Other Name: DIABA HP
Active Comparator: ISOSOURCE PROTEIN FIBRE
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
Group 2 will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric.
Other Name: ISS PROT FIB
Active Comparator: GLUCERNA SELECT
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
Group 3 will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric.
Other Name: GLUC SEL

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
    • Child degrees B-C.
    • Serum bilirubin higher than 3 mg/dL.
  • Patients with parenteral nutrition during study inclusion.
  • Informed consent absence.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01233726

Locations
Spain
Intensive Care Unit. Hospital Universitario 12 de Octubre
Madrid, Spain
Intensive Care Unit. Hospital Clinico Universitario de Valencia
Valencia, Spain
Sponsors and Collaborators
Vegenat, S.A.
Investigators
Principal Investigator: Alfonso Mesejo, PhD Hospital Clinico Universitario de Valencia
Principal Investigator: Juan Carlos Montejo, PhD Hospital Universitario 12 de Octubre
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vegenat, S.A.
ClinicalTrials.gov Identifier: NCT01233726     History of Changes
Other Study ID Numbers: IR2009  DIABET IR IDI-20080283 
Study First Received: October 29, 2010
Results First Received: December 18, 2015
Last Updated: July 20, 2016
Health Authority: Spain: Ministry of Health and Consumption
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Vegenat, S.A.:
Critical illness
Hyperglycemia
Mechanical Ventilation
Enteral nutrition
T-Diet plus Diabet IR
Malnutrition
Insulin resistance
Metabolic stress

Additional relevant MeSH terms:
Critical Illness
Hyperglycemia
Disease Attributes
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Phentermine
Central Nervous System Stimulants
Physiological Effects of Drugs
Appetite Depressants
Anti-Obesity Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 08, 2016