Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2024-07-01
2025-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Inulin 20 mg
Inulin 20 mg administrated orally q24h
Inulin 20 mg
Inulin can increase gut Bifidobacterium count. Bifidobacterium has beneficial effects on the metabolic profile and insulin resistance biomarkers.
Placebo
Matching placebo q24h
Placebo
Placebo
Interventions
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Inulin 20 mg
Inulin can increase gut Bifidobacterium count. Bifidobacterium has beneficial effects on the metabolic profile and insulin resistance biomarkers.
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* PCOS
* BMI ≥ 30 kg/m2
* Pregnancy
* Diabetes type 1
* Diabetes type 2
* Metabolic syndrome
* Use of drugs that can affect insulin resistance
* Weight loss greater than 10% in the last 6 months
18 Years
ALL
No
Sponsors
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University of Belgrade
OTHER
Responsible Party
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Marko Stojanovic
Assistant professor
Principal Investigators
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Marko A Stojanović, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Faculty of Medicine, University of Belgrade
Locations
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Faculty of Medicine; Clinical Center of Serbia, Clinic for Burns, Plastic and Reconstructive Surgery
Belgrade, , Serbia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MicroModifiER
Identifier Type: -
Identifier Source: org_study_id
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