Clinical trial NCT05532488: Inulin in Burn-induced Insulin Resistance
Official title: The Inulin Effect on Burn-induced Insulin Resistance: a Randomized, Double-blind Placebo-controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Burn Injury
Insulin Resistance
Post Burn Insulin Resistance
Lead sponsor: University of Belgrade
Sponsor class: OTHER
First posted: 2022-09-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in insulin resistance measured by HOMA-IR
timeFrame: Baseline and end of the study (6week)
measure: Change in fasting plasma glucose level
timeFrame: Baseline and end of the study (6week)
measure: Change in plasma insulin level
timeFrame: Baseline and end of the study (6week)
measure: Changes in insulin resistance measured by QUICKI
timeFrame: Baseline and end of the study (6week)
measure: Changes in HbA1c level
timeFrame: Baseline and end of the study (6week)
Secondary outcomes:
measure: Survival
timeFrame: 6 weeks
measure: Burn wound changes
timeFrame: 6 weeks
measure: Development of local and systemic infection
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Faculty of Medicine; Clinical Center of Serbia, Clinic for Burns, Plastic and Reconstructive Surgery
Study officials:
affiliation: Faculty of Medicine, University of Belgrade
name: Marko A Stojanović, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: