Clinical trial NCT02584907: Fat Based Enteral Nutrition for Blood Glucose Control in ICU
Official title: Effect of Fat Based Versus Glucose Based Enteral Nutrition on Serum Glucose Levels and Clinical Outcome in Hyperglycemic Patients in ICU
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperglycemia
Keywords: Critically ill
Diet
Blood glucose
Lead sponsor: Shahid Beheshti University
Sponsor class: OTHER
First posted: 2015-10-23
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this randomized, double-blind clinical trial, eligible hospitalized ICU patients with EN will be included. Patients will be divided into two groups. The control group with the standard EN and intervention group with high fat EN. 50% of the total fat will be provided by olive oil. Nutritional intake record form will be completed and daily calorie intake will be calculated. High fat EN feeding will be offered for 15 consecutive days maximally. At the end of the study mean blood glucose, duration of hospitalization and rate of infection will be compared in two groups.

Detailed description: In this randomized, double-blind clinical trial, 88 eligible hospitalized ICU patients with EN will be included. Written consent form will be completed. Physical examination will be done by specialist and nutritional care process will be offered by an RD. Demographic, laboratory and nutritional data will be extracted and entered in prepared form. Venous blood samples will be taken and laboratory values will be measured and recorded at specified times. Patients will be divided into two groups. The control group with the standard EN (Protein; 20% carbohydrate; 50% and fat; 30% from total calories) and intervention group with high fat EN (Protein; 20% carbohydrate; 35% and fat; 45% from total calories). 50% of the total fat will be provided by olive oil. Any feeding rout such as naso - gastric , Percutaneous endoscopic gastrostomy (PEG ) or Percutaneous endoscopic jejunostomy (PEJ) with Intermittent feeding protocol will be accepted feeding method . Nutritional intake record form will be completed and daily calorie intake will be calculated. High fat EN feeding will be offered for 15 consecutive days maximally

Eligibility criteria: Inclusion Criteria:

* Being on Enteral Nutrition
* BS≥ 200mg/dl
* Without Renal and Liver Failure
* Without Hyperlipidemia and Nephrotic Syndrome
* Without Infection
* Without Obesity

Exclusion Criteria:

* Death or Discharge before Day 7

Primary outcomes:
measure: Blood Glucose
timeFrame: 1 year
Secondary outcomes:
measure: Length of Stay in ICU
timeFrame: 1 year
measure: Occurrence of Infection
timeFrame: 1 year
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Faculty of Nutrition Sciences and Food Technology
Study officials:
affiliation: Faculty of Nutrition and Food Sciencees, Shahid Beheshti University of Medical Sciences
name: Zahra Vahdat Shariatpanahi, MD, Ph.D
role: STUDY_CHAIR
References:
citation: Wewalka M, Drolz A, Zauner C. Influence of fat-based versus glucose-based enteral nutrition formulas on glucose homeostasis. Crit Care. 2013; 17(Suppl 2): P250. Published online 2013 Mar 19. doi: 10.1186/cc12188. PMCID: PMC3642614.