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临床试验/NCT05532488
NCT05532488Unknown不适用

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

University of Belgrade1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
Changes in insulin resistance measured by QUICKI

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Placebo

Placebo Comparator

Matching placebo q24h

干预措施: Placebo (Other)

Inulin 20 mg

Experimental

Inulin 20 mg administrated orally q24h

干预措施: Inulin 20 mg (Dietary Supplement)

结局指标

主要结局

Changes in insulin resistance measured by QUICKI

时间窗: Baseline and end of the study (6week)

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

Change in plasma insulin level

时间窗: Baseline and end of the study (6week)

Change in plasma insulin levelin placebo and experimental group

Changes in insulin resistance measured by HOMA-IR

时间窗: 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

时间窗: Baseline and end of the study (6week)

Changes in fasting plasma glucose in placebo and experimental group

Changes in HbA1c level

时间窗: Baseline and end of the study (6week)

Changes in HbA1c level in placebo and experimental group

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marko Stojanovic

Assistant professor

University of Belgrade

研究点 (1)

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