Inulin in Burn-induced Insulin Resistance

Insulin Resistance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05532488
• Other study ID #: MicroModifiER
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: January 31, 2025

Study information

• Verified date: April 2024
• Source: University of Belgrade
• Contact: Marko A Stojanovic, MD, PhD
• Phone: 00381601435353
• Email: stojanovic.dr.marko[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burn Injury
• Burns
• Insulin Resistance

Intervention

Dietary Supplement:
• Inulin 20 mg
Inulin can increase gut Bifidobacterium count. Bifidobacterium has beneficial effects on the metabolic profile and insulin resistance biomarkers.

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
Serbia	Faculty of Medicine; Clinical Center of Serbia, Clinic for Burns, Plastic and Reconstructive Surgery	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
University of Belgrade

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Change in fasting plasma glucose level	Changes in fasting plasma glucose in placebo and experimental group	Baseline and end of the study (6week)
Primary	Change in plasma insulin level	Change in plasma insulin levelin placebo and experimental group	Baseline and end of the study (6week)
Primary	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)
Primary	Changes in HbA1c level	Changes in HbA1c level in placebo and experimental group	Baseline and end of the study (6week)
Secondary	Survival	The survival of patient in placebo and experimental group	6 weeks
Secondary	Burn wound changes	The change in diameter, tissue type and contraction of wound in placebo and experimental group	6 weeks
Secondary	Development of local and systemic infection	The developement of local and systhemic infection in placebo and experimental group	6 weeks