Inulin in Burn-induced Insulin Resistance

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Insulin Resistance; Burn Injury; Post Burn Insulin Resistance
• Intervention / Treatment: Other: Placebo; Dietary supplement: Inulin 20 mg

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marko A Stojanović, MD, PhD; Phone Number: 00381601435353; Email: stojanovic.dr.marko@gmail.com

Study Locations

• Serbia
  • Belgrade, Serbia, 11000
    • Faculty of Medicine; Clinical Center of Serbia, Clinic for Burns, Plastic and Reconstructive Surgery
    • Contact: Marko A Stojanović, MD, PhD; Phone Number: 00381601435353; Email: marko.stojanovic@med.bg.ac.rs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Belgrade
• Investigators: Principal Investigator: Marko A Stojanović, MD, PhD, Faculty of medicine; University of Belgrade

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2023
• Primary Completion (Anticipated): January 31, 2024
• Study Completion (Anticipated): January 31, 2024

Study Registration Dates

• First Submitted: September 4, 2022
• First Submitted That Met QC Criteria: September 4, 2022
• First Posted (Actual): September 8, 2022

Study Record Updates

• Last Update Posted (Actual): September 8, 2022
• Last Update Submitted That Met QC Criteria: September 4, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Wounds and Injuries; Hyperinsulinism; Burns; Insulin Resistance
• Other Study ID Numbers: MicroModifiER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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.
• IPD Sharing Time Frame: The date of interest will be available at the beginning of study and at least three years after the termination of the study
• IPD Sharing Access Criteria: On demanded
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No