Burn Injury, Insulin Resistance, Post Burn Insulin Resistance
Conditions
Brief 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.
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.
Interventions
DIETARY_SUPPLEMENTInulin 20 mg
Inulin can increase gut Bifidobacterium count. Bifidobacterium has beneficial effects on the metabolic profile and insulin resistance biomarkers.
OTHERPlacebo
Placebo
Sponsors
University of Belgrade
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in HbA1c level | Baseline and end of the study (6week) | Changes in HbA1c level in placebo and experimental group |
| Change in fasting plasma glucose level | Baseline and end of the study (6week) | Changes in fasting plasma glucose in placebo and experimental group |
| Change in plasma insulin level | Baseline and end of the study (6week) | Change in plasma insulin levelin placebo and experimental group |
| Changes in insulin resistance measured by QUICKI | Baseline and end of the study (6week) | Changes in insulin resistance in placebo and experimental group measured by QUICKI |
| Changes in insulin resistance measured by HOMA-IR | Baseline and end of the study (6week) | Changes in insulin resistance in placebo and experimental group measured by HOMA-IR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Burn wound changes | 6 weeks | The change in diameter, tissue type and contraction of wound in placebo and experimental group |
| Development of local and systemic infection | 6 weeks | The developement of local and systhemic infection in placebo and experimental group |
| Survival | 6 weeks | The survival of patient in placebo and experimental group |
Countries
Serbia
Contacts
Primary ContactMarko A Stojanović, MD, PhD
Outcome results
None listed