Enteral Nutrition and Glucose Homeostasis

Hyperglycemia Stress Clinical Trial

Official title: Effect of Different Enteral Nutrition Formulas on Glucose Homeostasis

Status Completed

Clinical Trial Summary

Different enteral nutrition formulas are tested on their effect on glucose homeostasis in critically ill medical patients.

Clinical Trial Description

To assess whether enteral nutrition fomulas based either on fat or glucose influence glucose homeostasis differently in critically ill medical patients. All patients are admitted to a tertiary ICU and require mechanical ventilation.

Resting energy expenditure is assessed at baseline in the fasting state by indirect calorimetry. Total energy demand is calculated and patients are randomized to receive fat-based or glucose-based nutrition which is administered continously for 7 days. Indirect calorimetry is repeated on days 3 and 7 under continous nutrition. During the study period, various parameters of glucose homeostasis are assessed. Daily, there will be at least 3 measurements of blood glucose, more if the treating physician deems it necessary. Daily average glucose, daily glucose variability, overall area under the curve for glucose are calculated. Furthermore, energy intake by nutrition, medications (i.e. propofol), and glucose infusion, as well as substrate intake, and insulin demand per 24hrs are determined daily. Adverse effects such as episodes of hyper- or hypoglycemia, cholestasis, hypertriglyceridemia, diarrhea, vomiting, and the amount of gastric residual volume are noted. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperglycemia
• Hyperglycemia Stress

• NCT number: NCT03012867
• Study type: Interventional
• Source: Medical University of Vienna
• Status: Completed
• Phase: Phase 4
• Start date: June 2010
• Completion date: September 2016