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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inulin 20 mg | Experimental | Inulin 20 mg administrated orally q24h |
|
| Placebo | Placebo Comparator | Matching placebo q24h |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inulin 20 mg | Dietary Supplement | Inulin can increase gut Bifidobacterium count. Bifidobacterium has beneficial effects on the metabolic profile and insulin resistance biomarkers. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marko A Stojanović, MD, PhD | Contact | 00381601435353 | stojanovic.dr.marko@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Marko A Stojanović, MD, PhD | University of Belgrade | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine; Clinical Center of Serbia, Clinic for Burns, Plastic and Reconstructive Surgery | Belgrade | 11000 | Serbia |
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.
The date of interest will be available at the beginning of study and at least three years after the termination of the study
On demanded
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| ID | Term |
|---|---|
| D002056 | Burns |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D007444 | Inulin |
| ID | Term |
|---|---|
| D013213 | Starch |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 |
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| Placebo | Other | Placebo |
|
| 6 weeks |
| Development of local and systemic infection | The developement of local and systhemic infection in placebo and experimental group | 6 weeks |
| D009750 |
| Nutritional and Metabolic Diseases |
| Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005630 | Fructans |
| D011134 | Polysaccharides |