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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
Results First Received: December 18, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Conditions: Critical Illness
Hyperglycemia
Dietary Modification
Metabolic Stress Hyperglycemia
Mechanical Ventilation Complication
Interventions: Dietary Supplement: T-Diet plus Diabet IR
Dietary Supplement: ISOSOURCE PROTEIN FIBRE
Dietary Supplement: GLUCERNA SELECT

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study examines whether a high-protein diabetes-specific formula reduces insulin needs, improves glycemic control and reduces ICU-adquired infection in critically ill, hyperglycemic patients on mechanical ventilation (MV)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study was performed over the period April 2010 to May 2012. A website was constructed to record data and to randoize patients to each EN formula. Data were collected online using an electronic case report form.

Reporting Groups
  Description
DIABA HP

Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric

Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.

DIABA HP group received, 25 kcal / kg /day for 28 days, via gastric or transpyloric.

ISOSOURCE PROTEIN FIBRE

Patients of this group received 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

ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.

ISOSOURCE PROTEIN FIBRE group received, 25 kcal / kg / day for 28 days, via gastric or transpyloric.

GLUCERNA SELECT

Patients of this group received 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

GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.

GLUCERNA SELECT group will received 25 kcal / kg / day for 28 days, via gastric or transpyloric.


Participant Flow:   Overall Study
    DIABA HP   ISOSOURCE PROTEIN FIBRE   GLUCERNA SELECT
STARTED   53   53   53 
COMPLETED   52   53   52 
NOT COMPLETED   1   0   1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
DIABA HP

Patients of this group received new-generation diabetes-specific high-protein formula (Diaba HP®, Vegenat, Badajoz, Spain); as unique nutritional support throughout the day, receiving 25 kcal / kg / day (from the first 48 hours after checking tolerance) via gastric or transpyloric

Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.

DIABA HP group received, 25 kcal / kg/ day for 28 days, via gastric or transpyloric.

ISOSOURCE PROTEIN FIBRE

Patients of this group will received ISOSOURCE PROTEIN FIBRE (Nestlé Health Science, barcelona, Spain) 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: Isosource protein fibre is a complete high protein diet with fibre mixture.

ISOSOURCE PROTEIN FIBRE group received, 25 kcal / kg / day for 28 days, via gastric or transpyloric.

GLUCERNA SELECT

Patients of this group will receive GLUCERNA SELECT (Abbott Nutrition, Madrid, Spain) 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: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.

GLUCERNA SELECT group received 25 kcal / kg / day for 28 days, via gastric or transpyloric.

Total Total of all reporting groups

Baseline Measures
   DIABA HP   ISOSOURCE PROTEIN FIBRE   GLUCERNA SELECT   Total 
Overall Participants Analyzed 
[Units: Participants]
 52   53   52   157 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 57 
 (43 to 70) 
 60 
 (45 to 71) 
 58 
 (46 to 68) 
 58 
 (43 to 71) 
Gender 
[Units: Participants]
       
Female   15   10   13   38 
Male   37   43   39   119 
Body Mass Index (BMI) 
[Units: Kg/m^2]
Median (Inter-Quartile Range)
 26 
 (24 to 29) 
 26 
 (24 to 28) 
 26 
 (24 to 27) 
 26 
 (24 to 29) 
APACHE II [1] 
[Units: Units on a scale]
Median (Inter-Quartile Range)
 17 
 (14 to 23) 
 19 
 (15 to 22) 
 19 
 (16 to 23) 
 19 
 (14 to 23) 
[1]

Acute Physiology and Chronic Health Evaluation II

Scale: 0 to 71: based on several measures: at higher score, more severe illness and greater risk of death.

SOFA score [1] 
[Units: Units on a scale]
Median (Inter-Quartile Range)
 8 
 (6 to 14) 
 7 
 (5 to 12) 
 7 
 (4 to 12) 
 8 
 (4 to 14) 
[1]

Sepsis-related Organ Failure Assessment score.

Score:

0-6: 10% of mortality; 7-9: 15-20% of mortality; 10-12: 40-50% of mortality; 13-14: 50-60 % of mortality; 15: >80% of mortality; 16-24: >90% of mortality.

Calorie requirements 
[Units: Kcal/day]
Geometric Mean (Standard Deviation)
 1690.4  (384.9)   1707.1  (275.4)   1728.2  (309.2)   1708.6  (323.2) 
Start of EN [1] 
[Units: Hours]
Median (Inter-Quartile Range)
 23.4 
 (18.1 to 27.2) 
 25.1 
 (19.6 to 26.2) 
 26.7 
 (21.3 to 28) 
 25.1 
 (18.1 to 28) 
[1] Start of Enteral Nutrition: elapsed time from admission to start enteral nutrition
Noninsulin-dependent diabetes 
[Units: Participants]
 11   7   12   30 
HbA1c 
[Units: Percentaje of glycated hemoglobin]
Mean (Standard Deviation)
 6.34  (1.38)   5.76  (0.95)   6.07  (1.39)   6.1  (1.24) 
Capillary glucose level [1] 
[Units: mg/dL]
Mean (Standard Deviation)
 148.8  (38.8)   149.9  (38.9)   151.5  (39.23)   150  (38.98) 
[1] Measured after fasting and without insulin infusion for at least 8 hours
Plasma glucose level [1] 
[Units: mg/dL]
Mean (Standard Deviation)
 152.1  (54.6)   147.01  (55.93)   152.1  (57.12)   150.4  (55.88) 
[1] Measured after fasting and without insulin infusion for at least 8 hours
Insulinemia [1] 
[Units: microU/mL]
Mean (Standard Deviation)
 21.59  (36.06)   17.39  (23.77)   19.15  (20.5)   19.38  (26.78) 
[1] Measured after fasting and without insulin infusion for at least 8 hours
C-peptide [1] 
[Units: ng/mL]
Mean (Standard Deviation)
 4.61  (3.24)   4.49  (2.92)   4.27  (3.67)   4.46  (3.28) 
[1] Measured after fasting and without insulin infusion for at least 8 hours
HOMA2 IR [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 2.94  (4.19)   2.48  (2.76)   3.38  (2.37)   2.93  (3.11) 
[1]

HOMA 2: Homeostasis Model Assessment IR: Insulin Resistance. Homeostatic model assessment (HOMA) is a method for assessing β-cell function and insulin resistance (IR) from basal (fasting) glucose and insulin or C-peptide concentrations.

The HOMA model compares favorably with other models and has the advantage of requiring only a single plasma sample assayed for insulin and glucose. Higher values represent higher insulinemia.

HOMA2 %B [1] 
[Units: % of beta cell function]
Mean (Standard Deviation)
 102.6  (57.81)   110.5  (74.34)   96.55  (85.09)   103.21  (72.41) 
[1]

HOMA 2: Homeostasis Model Assessment B: Beta cell function.

Homeostatic model assessment (HOMA) is a method for assessing β-cell function and insulin resistance (IR) from basal (fasting) glucose and insulin or C-peptide concentrations.

HOMA2 %S [1] 
[Units: % of insulin sensitivity]
Mean (Standard Deviation)
 79.12  (75.2)   69.6  (48.7)   68.09  (66.9)   72.27  (63.6) 
[1] HOMA2: Homeostasis Model Assessment S: Insulin Sensitivity
Infection [1] 
[Units: Participants]
 13   15   8   36 
[1] Number of patients with infection from any source
Diagnostic group: Medical 
[Units: Participants]
 32   36   30   98 
Diagnostic group: Trauma 
[Units: Participants]
 13   9   15   37 
Diagnostic group: Surgery 
[Units: Participants]
 7   8   7   22 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Measure of Biochemical Parameters and Evaluation of Infectious Complications 1   [ Time Frame: 28 days post-admission ]

2.  Primary:   Measure of Biochemical Parameters and Evaluation of Infectious Complications 2   [ Time Frame: 28 days post-admission ]

3.  Primary:   Measure of Biochemical Parameters and Evaluation of Infectious Complications 3   [ Time Frame: 28 days post-admission ]

4.  Primary:   Measure of Biochemical Parameters and Evaluation of Infectious Complications 4   [ Time Frame: 28 days post-admission ]

5.  Primary:   Measure of Biochemical Parameters and Evaluation of Infectious Complications 5   [ Time Frame: 28 days post-admission ]

6.  Primary:   Primary Outcome: Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.1   [ Time Frame: 28 days post-admission ]

7.  Primary:   Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.2   [ Time Frame: 28 days post-admission ]

8.  Secondary:   Assessment of Critical Ill Patients Progress During Hospital Stay 1   [ Time Frame: 100 days of treatment ]

9.  Secondary:   Assessment of Critical Ill Patients Progress During Hospital Stay 2   [ Time Frame: 28 days post-admission ]

10.  Secondary:   Assessment of Critical Ill Patients Progress During Hospital Stay 3   [ Time Frame: 28 days post-admission ]

11.  Secondary:   Assessment of Critical Ill Patients Progress During Hospital Stay 4   [ Time Frame: 100 days of treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No overall limitations and caveats have been observed and/or registered related with the products intake during the clinical trial period.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Alfonso Mesejo
Organization: Intensive Care Unit, Hospital Clínico Universitario
phone: 961 97 35 00
e-mail: mesejo_alf@gva.es


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 ( Other Identifier: VEGENAT, S.A. )
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