Burn InjuryNCT05532488
Inulin in Burn-induced Insulin Resistance
A study testing Inulin 20 mg in people with Burn Injury and Insulin Resistance, run by University of Belgrade at 1 site in Serbia.
Trial summary
In this clinical trial, investigators will test the effects of dietary supplement inulin, on the reduction of insulin resistance developed as a result of burn injuryy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burn Injury, Insulin Resistance, Post Burn Insulin Resistance
- What is being tested?
- Inulin 20 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSerbia
- Study dates
- 1 Jul 2024to 31 Jan 2025
- Phase
- Interventional
- 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
- Informed consent and willingness in study participation
- The age of the respondent greater than or equal to 18 years at the time of signing the informed consent
- Burns requiring in-hospital treatment
- insulin resistance detected on the fifth day of admission to the hospital
Who cannot join
- Documented pre-existing insulin resistance
- PCOS
- BMI ≥ 30 kg/m2
- Pregnancy
- Diabetes type 1
- Diabetes type 2
Show all 9Show fewer
- Metabolic syndrome
- Use of drugs that can affect insulin resistance
- Weight loss greater than 10% in the last 6 months
Trial locations and contacts
1 site in 1 country.
Serbia1 site
Faculty of Medicine; Clinical Center of Serbia, Clinic for Burns, Plastic and Reconstructive Surgery
Belgrade, 11000
Marko A Stojanović, MD, PhD, 00381601435353, marko.stojanovic@med.bg.ac.rs
About this study
Official title: The Inulin Effect on Burn-induced Insulin Resistance: a Randomized, Double-blind Placebo-controlled Pilot Trial
In this clinical trial, investigators will test the effects of dietary supplement inulin, on the reduction of insulin resistance developed as a result of burn injuryy.
Read the detailed description
As a consequence of burn injury, an exaggerated inflammatory response is developing in parallel with metabolic changes, which led to the development of hyperglycemia and insulin resistance. The post burn-injury insulin resistance is different in comparison to other trauma-induced insulin resistance. The main difference is the length. More precisely postburn-injury insulin resistance lasts longer than insulin resistance developed after other traumas. Insulin resistance can persist for years after the burn heals.
Inulin is a heterogeneous mixture of fructose polymers that are widely distributed in nature as storage of carbohydrates in plants. This mixture of fructose has nutritional value, but also affects general health, reducing the risk of developing various diseases. Inulin prevents gastrointestinal complications such as constipation, increases the resorption of minerals from the gastrointestinal tract, stimulates the immune system, and functions as a prebiotic, but can also affect insulin resistance in patients with metabolic syndrome.
The hypothesis: The everyday inulin can affect postburn-injury insulin resistance.
To investigate the effect of inulin on patients with postburn-injury insulin resistance a prospective, double-blind, randomized, and placebo-controlled clinical trial will be performed. This initial trial is a pilot trial. The pilot trial will be performed to assess the safety of treatment or interventions and recruitment potentials, examine the randomization and blinding process, increase the researchers' experience with the study methods and interventions, and provide estimates for sample size calculation for the main study.
- Being tested
- Inulin 20 mg, Placebo
- Medical subject headings
- Burns, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inulin 20 mgDietary supplement
Inulin can increase gut Bifidobacterium count. Bifidobacterium has beneficial effects on the metabolic profile and insulin resistance biomarkers.
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Inulin 20 mg | Experimental | Inulin 20 mg administrated orally q24h Receives: Dietary Supplement: Inulin 20 mg |
| Placebo | Placebo comparator | Matching placebo q24h Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in insulin resistance measured by HOMA-IR
Changes in insulin resistance in placebo and experimental group measured by HOMA-IR
Measured: Baseline and end of the study (6week)
Change in fasting plasma glucose level
Changes in fasting plasma glucose in placebo and experimental group
Measured: Baseline and end of the study (6week)
Change in plasma insulin level
Change in plasma insulin levelin placebo and experimental group
Measured: Baseline and end of the study (6week)
Changes in insulin resistance measured by QUICKI
Changes in insulin resistance in placebo and experimental group measured by QUICKI
Measured: Baseline and end of the study (6week)
Changes in HbA1c level
Changes in HbA1c level in placebo and experimental group
Measured: Baseline and end of the study (6week)
Secondary outcomes (3)
Survival
The survival of patient in placebo and experimental group
Measured: 6 weeks
Burn wound changes
The change in diameter, tissue type and contraction of wound in placebo and experimental group
Measured: 6 weeks
Development of local and systemic infection
The developement of local and systhemic infection in placebo and experimental group
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start1 Jul 2024 (estimated)
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn InjuryStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Belgrade
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marko Stojanovic, University of Belgrade
- Investigators
- Marko A Stojanović, MD, PhD, Principal investigator, University of Belgrade
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05532488
- Sponsor's protocol ID
- MicroModifiER
- Status last verified
- Apr 2024
- First submitted
- 4 Sep 2022
- Last updated
- 26 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol will be published before the beginning of the study. All of the other necessary information regarding the study will be available at Zenodo repository before publishing the data.
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Inulin Effect on Burn-induced Insulin Resistance: a Randomized, Double-blind Placebo-controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT05532488
- Acronym / sponsor ID
- MicroModifiER
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of BelgradeUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 8 Sep 2022 (actual)
- 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.
In this clinical trial, investigators will test the effects of dietary supplement inulin, on the reduction of insulin resistance developed as a result of burn injuryy.
Detailed description
As a consequence of burn injury, an exaggerated inflammatory response is developing in parallel with metabolic changes, which led to the development of hyperglycemia and insulin resistance. The post burn-injury insulin resistance is different in comparison to other trauma-induced insulin resistance. The main difference is the length. More precisely postburn-injury insulin resistance lasts longer than insulin resistance developed after other traumas. Insulin resistance can persist for years after the burn heals.
Inulin is a heterogeneous mixture of fructose polymers that are widely distributed in nature as storage of carbohydrates in plants. This mixture of fructose has nutritional value, but also affects general health, reducing the risk of developing various diseases. Inulin prevents gastrointestinal complications such as constipation, increases the resorption of minerals from the gastrointestinal tract, stimulates the immune system, and functions as a prebiotic, but can also affect insulin resistance in patients with metabolic syndrome.
The hypothesis: The everyday inulin can affect postburn-injury insulin resistance.
To investigate the effect of inulin on patients with postburn-injury insulin resistance a prospective, double-blind, randomized, and placebo-controlled clinical trial will be performed. This initial trial is a pilot trial. The pilot trial will be performed to assess the safety of treatment or interventions and recruitment potentials, examine the randomization and blinding process, increase the researchers' experience with the study methods and interventions, and provide estimates for sample size calculation for the main study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inulin 20 mg | Experimental | Dietary Supplement: Inulin 20 mgInulin 20 mg administrated orally q24h |
| Placebo | Placebo comparator | Other: PlaceboMatching placebo q24h |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed consent and willingness in study participation
- The age of the respondent greater than or equal to 18 years at the time of signing the informed consent
- Burns requiring in-hospital treatment
- insulin resistance detected on the fifth day of admission to the hospital
Key exclusion criteria (9 listed)
- Documented pre-existing insulin resistance
- PCOS
- BMI ≥ 30 kg/m2
- Pregnancy
- Diabetes type 1
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 |
|---|---|---|
| Inulin 20 mgInulin can increase gut Bifidobacterium count. Bifidobacterium has beneficial effects on the metabolic profile and insulin resistance biomarkers. | Dietary supplement | Inulin 20 mg |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Changes in insulin resistance measured by HOMA-IR
Time frame: Baseline and end of the study (6week)
Changes in insulin resistance in placebo and experimental group measured by HOMA-IR
Change in fasting plasma glucose level
Time frame: Baseline and end of the study (6week)
Changes in fasting plasma glucose in placebo and experimental group
Change in plasma insulin level
Time frame: Baseline and end of the study (6week)
Change in plasma insulin levelin placebo and experimental group
Changes in insulin resistance measured by QUICKI
Time frame: Baseline and end of the study (6week)
Changes in insulin resistance in placebo and experimental group measured by QUICKI
Changes in HbA1c level
Time frame: Baseline and end of the study (6week)
Changes in HbA1c level in placebo and experimental group
3 secondary outcomes
Survival
Time frame: 6 weeks
Burn wound changes
Time frame: 6 weeks
Development of local and systemic infection
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Individual participant dataSharing planned: Yes. The study protocol will be published before the beginning of the study. All of the other necessary information regarding the study will be available at Zenodo repository before publishing the data.
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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.
Marko A Stojanović, MD, PhD principal investigator
University of Belgrade
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inulin 20 mg in people with Burn Injury and Insulin Resistance, run by University of Belgrade at 1 site in Serbia.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 26 Apr 2024. 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 Serbia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marko A Stojanović, MD, PhD (00381601435353, stojanovic.dr.marko@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in insulin resistance measured by HOMA-IR (time frame: Baseline and end of the study (6week)). The study lists 5 primary outcomes in all. 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 26 Apr 2024.