Inulin in Burn-induced Insulin Resistance

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Inulin Effect on Burn-induced Insulin Resistance: a Randomized, Double-blind Placebo-controlled Pilot Trial

Conditions
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Burn Injury, Insulin Resistance, Post Burn Insulin Resistance

Intervention / Treatment
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* Dietary Supplement: Inulin 20 mg
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Documented pre-existing insulin resistance 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inulin 20 mg<br>Inulin 20 mg administrated orally q24h | Dietary Supplement: Inulin 20 mg<br>* Inulin can increase gut Bifidobacterium count. Bifidobacterium has beneficial effects on the metabolic profile and insulin resistance biomarkers.<br>|
| Placebo Comparator: Placebo<br>Matching placebo q24h | Other: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in insulin resistance measured by HOMA-IR | Changes in insulin resistance in placebo and experimental group measured by HOMA-IR | Baseline and end of the study (6week) | 
| Change in fasting plasma glucose level | Changes in fasting plasma glucose in placebo and experimental group | Baseline and end of the study (6week) | 
| Change in plasma insulin level | Change in plasma insulin levelin placebo and experimental group | 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 | Baseline and end of the study (6week) | 
| Changes in HbA1c level | Changes in HbA1c level in placebo and experimental group | Baseline and end of the study (6week) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | The survival of patient in placebo and experimental group | 6 weeks | 
| Burn wound changes | The change in diameter, tissue type and contraction of wound in placebo and experimental group | 6 weeks | 
| Development of local and systemic infection | The developement of local and systhemic infection in placebo and experimental group | 6 weeks |