Fat Based Enteral Nutrition for Blood Glucose Control in ICU

Hyperglycemia Clinical Trial

Official title:

Effect of Fat Based Versus Glucose Based Enteral Nutrition on Serum Glucose Levels and Clinical Outcome in Hyperglycemic Patients in ICU

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02584907
• Other study ID #: 1395/34199
• Status: Completed
• Phase: N/A
• First received: October 19, 2015
• Last updated: April 13, 2017
• Start date: October 2015
• Est. completion date: April 1, 2017

Study information

• Verified date: April 2017
• Source: Shahid Beheshti University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: April 1, 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperglycemia

Intervention

Other:
• High Fat Enteral Nutrition
Diet in high fat group will be 20% from protein, 45% from fat and 35% from carbohydrate

Locations

Country	Name	City	State
Iran, Islamic Republic of	Faculty of Nutrition Sciences and Food Technology	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Glucose		1 year
Secondary	Length of Stay in ICU		1 year
Secondary	Occurrence of Infection		1 year

External Links

•   Critical Care