Hyperglycemia StressPhase 4NCT03012867
Enteral Nutrition and Glucose Homeostasis
A Phase 4 study testing Diben, Fresenius Kabi and Fresubin original fibre, Fresenius Kabi in people with Hyperglycemia Stress, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Different enteral nutrition formulas are tested on their effect on glucose homeostasis in critically ill medical patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperglycemia Stress
- What is being tested?
- Diben, Fresenius Kabi and Fresubin original fibre, Fresenius Kabi
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2010to Sep 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- medical patient with need for mechanical ventilation
- FiO2 requirement < 60%
- need for nutritional support
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Different Enteral Nutrition Formulas on Glucose Homeostasis
Different enteral nutrition formulas are tested on their effect on glucose homeostasis in critically ill medical patients.
Read the 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.
- Conditions
- Hyperglycemia Stress
- Being tested
- Diben, Fresenius Kabi, Fresubin original fibre, Fresenius Kabi
- Keywords
- criticall illness, enteral nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diben, Fresenius KabiOther
Patients receive Diben continously for 7 days
Fresubin original fibre, Fresenius KabiOther
Patients receive Fresubin original fibre continously for 7 days
| Study group | Role | What they receive |
|---|---|---|
| fat-based | Active comparator | Patients receive a fat-based enteral nutrition formula, which is routinely used as standard care in our ICU Receives: Other: Diben, Fresenius Kabi |
| glucose-based | Active comparator | Patients receive a glucose-based enteral nutrition formula, which is routinely used as standard care in our ICU Receives: Other: Fresubin original fibre, Fresenius Kabi |
What is being measured
The primary outcome is the main question the study is designed to answer.
average daily glucose
Measured: up to 7 days
Secondary outcomes (3)
insulin demand per 24 hrs
Measured: up to 7 days
glucose variability
Measured: up to 7 days
nutrition-related side effects
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startJun 2010
- Primary completionJul 2014
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperglycemia StressStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marlene Wewalka, Medical University of Vienna
- Investigators
- Christian Zauner, MD, Principal investigator, Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterology and Hepatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03012867
- Sponsor's protocol ID
- NUTR1
- Status last verified
- Jan 2017
- First submitted
- 5 Jan 2017
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Enteral Nutrition Formulas on Glucose Homeostasis
- ClinicalTrials.gov ID
- NCT03012867
- Acronym / sponsor ID
- NUTR1
- Conditions
- Hyperglycemia Stress
- Keywords
- criticall illness, enteral nutrition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 6 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fat-based | Active comparator | Other: Diben, Fresenius KabiPatients receive a fat-based enteral nutrition formula, which is routinely used as standard care in our ICU |
| glucose-based | Active comparator | Other: Fresubin original fibre, Fresenius KabiPatients receive a glucose-based enteral nutrition formula, which is routinely used as standard care in our ICU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- medical patient with need for mechanical ventilation
- FiO2 requirement < 60%
- need for nutritional support
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diben, Fresenius KabiPatients receive Diben continously for 7 days | Other | fat-based |
| Fresubin original fibre, Fresenius KabiPatients receive Fresubin original fibre continously for 7 days | Other | glucose-based |
Primary outcome
average daily glucose
Time frame: up to 7 days
3 secondary outcomes
insulin demand per 24 hrs
Time frame: up to 7 days
glucose variability
Time frame: up to 7 days
nutrition-related side effects
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
- Individual participant dataSharing planned: No
Related trials for Hyperglycemia Stress
Not yet recruitingObservational study
Stress Hyperglycemia Ratio and Glucose Variability in Critically Ill Patients
Critical Illness, Hyperglycemia
Not yet recruitingPhase 4
Assessing Trauma-related Links Between Affective and Metabolic Systems
Posttraumatic Stress Disorder, Metabolic Syndrome
Not yet recruitingObservational study
Prognostic Value of Stress Hyperglycemia Ratio in Critically Ill Patients
Critical Illness, Hyperglycemia
Recruiting
Wild Blueberries for Gut, Brain, and Cardiometabolic Health in Prediabetes
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Female
Active, not recruiting
The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes
Hyperglycemia, Dyslipidemias
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Zauner, MD principal investigator
Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterology and Hepatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diben, Fresenius Kabi and Fresubin original fibre, Fresenius Kabi in people with Hyperglycemia Stress, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
average daily glucose (time frame: up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2017.