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Clinical Trials/NCT05532488
NCT05532488Not yet recruitingNot Applicable

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

University of Belgrade2 sites in 1 country40 target enrollmentStarted: July 1, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
40
Locations
2
Primary Endpoint
Change in plasma insulin level

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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
  • 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

Outcomes

Primary Outcomes

Change in plasma insulin level

Time Frame: Baseline and end of the study (6week)

Change in plasma insulin levelin placebo and experimental group

Changes in insulin resistance measured by HOMA-IR

Time Frame: Baseline and end of the study (6week)

Changes in insulin resistance in placebo and experimental group measured by HOMA-IR

Change in fasting plasma glucose level

Time Frame: Baseline and end of the study (6week)

Changes in fasting plasma glucose in placebo and experimental group

Changes in HbA1c level

Time Frame: Baseline and end of the study (6week)

Changes in HbA1c level in placebo and experimental group

Changes in insulin resistance measured by QUICKI

Time Frame: Baseline and end of the study (6week)

Changes in insulin resistance in placebo and experimental group measured by QUICKI

Secondary Outcomes

  • Development of local and systemic infection(6 weeks)
  • Survival(6 weeks)
  • Burn wound changes(6 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Marko Stojanovic

Assistant professor

University of Belgrade

Study Sites (2)

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