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OpenTrials
Completed

NCT Number: NCT03012867

Enteral Nutrition and Glucose Homeostasis

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical University of Vienna

Vienna, 1090, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Diben, Fresenius Kabi

Other

Patients receive Diben continously for 7 days

Fresubin original fibre, Fresenius Kabi

Other

Patients receive Fresubin original fibre continously for 7 days

Primary outcomes

  1. average daily glucose

    Time frame: up to 7 days

Secondary outcomes

  1. insulin demand per 24 hrs

    Time frame: up to 7 days

  2. glucose variability

    Time frame: up to 7 days

  3. nutrition-related side effects

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Effect of Different Enteral Nutrition Formulas on Glucose Homeostasis

Important dates

Study start
2010
Primary completion
2014
Study completion
2016
First posted
Jan 6, 2017
Registry last updated
Jan 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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