Inulin in Burn-induced Insulin Resistance

NCT05532488 | Not Yet Recruiting

• 1 other identifier: MicroModifiER
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Burn Injury; Insulin Resistance; Post Burn Insulin Resistance

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Survival

  6 weeks

• Burn wound changes

  6 weeks

• Development of local and systemic infection

  6 weeks

Study Arms (2)

Inulin 20 mg

EXPERIMENTAL

Inulin 20 mg administrated orally q24h

Dietary Supplement: Inulin 20 mg

Placebo

PLACEBO COMPARATOR

Matching placebo q24h

Other: Placebo

Interventions

Inulin 20 mg DIETARY_SUPPLEMENT

Inulin can increase gut Bifidobacterium count. Bifidobacterium has beneficial effects on the metabolic profile and insulin resistance biomarkers.

Inulin 20 mg

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Belgrade: lead

Study Sites (1)

Faculty of Medicine; Clinical Center of Serbia, Clinic for Burns, Plastic and Reconstructive Surgery

Belgrade, 11000, Serbia

Location

MeSH Terms

Conditions

Burns; Insulin Resistance

Interventions

Inulin

Condition Hierarchy (Ancestors)

Wounds and Injuries; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides

Study Officials

• Marko A Stojanović, MD, PhD

  University of Belgrade

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marko A Stojanović, MD, PhD

CONTACT

00381601435353; stojanovic.dr.marko@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: September 4, 2022
• First Posted: September 8, 2022
• Study Start: July 1, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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
• Access Criteria: On demanded

Locations

SE (1)