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Enteral Nutrition and Glucose Homeostasis

Effect of Different Enteral Nutrition Formulas on Glucose Homeostasis

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03012867
Enrollment
60
Registered
2017-01-06
Start date
2010-06-30
Completion date
2016-09-30
Last updated
2017-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperglycemia Stress

Keywords

criticall illness, enteral nutrition

Brief summary

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

Detailed 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.

Interventions

OTHERDiben, Fresenius Kabi

Patients receive Diben continously for 7 days

OTHERFresubin original fibre, Fresenius Kabi

Patients receive Fresubin original fibre continously for 7 days

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
average daily glucoseup to 7 days

Secondary

MeasureTime frame
insulin demand per 24 hrsup to 7 days
glucose variabilityup to 7 days
nutrition-related side effects7 days

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026