Enteral Nutrition and Glucose Homeostasis

Hyperglycemia Stress Clinical Trial

Official title:

Effect of Different Enteral Nutrition Formulas on Glucose Homeostasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03012867
• Other study ID #: NUTR1
• Status: Completed
• Phase: Phase 4
• First received: January 5, 2017
• Last updated: January 5, 2017
• Start date: June 2010
• Est. completion date: September 2016

Study information

• Verified date: January 2017
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2016
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• medical patient with need for mechanical ventilation

• FiO2 requirement < 60%

• need for nutritional support

Exclusion Criteria:

• contraindications against nutritional therapy

• hemodynamic shock (lactate of = 4 mmol/l)

• severe hypertriglyceridemia (= 450 mg/dl)

• contraindications against enteral nutrion (intestinal obstruction, disruption or severe bleeding of upper gastrointestinal tract)

Study Design

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

Related Conditions & MeSH terms

• Hyperglycemia
• Hyperglycemia Stress

Intervention

Other:
• Diben, Fresenius Kabi
Patients receive Diben continously for 7 days
• Fresubin original fibre, Fresenius Kabi
Patients receive Fresubin original fibre continously for 7 days

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	average daily glucose		up to 7 days	No
Secondary	insulin demand per 24 hrs		up to 7 days	No
Secondary	glucose variability		up to 7 days	No
Secondary	nutrition-related side effects		7 days	No