Inulin in Burn-induced Insulin Resistance

University of Belgrade

Status: Not yet enrolling

Conditions: Insulin Resistance; Post Burn Insulin Resistance; Burn Injury

Treatments: Other: Placebo; Dietary Supplement: Inulin 20 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05532488

MicroModifiER

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Inulin 20 mg

Experimental group

Description:

Inulin 20 mg administrated orally q24h

Treatment:

Dietary Supplement: Inulin 20 mg

Placebo

Placebo Comparator group

Description:

Matching placebo q24h

Treatment:

Other: Placebo