跳至主要内容
临床试验/NCT06491394
NCT06491394已完成4 期

Effect of Lactoferrin Administration on Rhabdomyolysis-induced Heart and Kidney Injury in Rats

Aswan University Hospital1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年11月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
24
试验地点
1
主要终点
AMPK levels

研究概览

简要总结

This study focuses on detecting the possible beneficial effect of Lactoferrin (Lf) administration on the kidney and the heart of glycerol-induced rhabdomyolysis (RM) in rats and its relation to ferroptosis and AMPK/Nrf2/ HO-1 signalling pathway. The main questions it aims to answer are:

  1. Is Lf administration 30 min. before or after RM induction in rats beneficial to kidneys and heart?
  2. When administered to glycerol-induced rats, does Lf act by upregulating the AMPK/Nrf2/ HO-1 signalling pathway and inhibiting ferroptosis?

研究设计

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

入排标准

年龄范围
10 Weeks 至 12 Weeks(Child)
性别
Male
接受健康志愿者

入选标准

  • • Twenty-four healthy male Wistar Albino rats weighing from 250 to 300 g

排除标准

  • No exclusion criteria as this study is used to detect effects of drugs on experimental rats.

研究组 & 干预措施

Control

Sham Comparator

Normal saline will be administered once to rats intramuscularly (10 mL/kg).

干预措施: iron (Diagnostic Test)

Control

Sham Comparator

Normal saline will be administered once to rats intramuscularly (10 mL/kg).

干预措施: MDA, TAC, and GSH (Diagnostic Test)

Control

Sham Comparator

Normal saline will be administered once to rats intramuscularly (10 mL/kg).

干预措施: Nrf2 (Diagnostic Test)

Control

Sham Comparator

Normal saline will be administered once to rats intramuscularly (10 mL/kg).

干预措施: AMPK (Diagnostic Test)

Control

Sham Comparator

Normal saline will be administered once to rats intramuscularly (10 mL/kg).

干预措施: HO-1 (Diagnostic Test)

RM

Active Comparator

A single intramuscular injection of GLY 50% (10 mL/kg) after 24-h water deprivation and normal saline (4ml/kg) will be administered by gavage.

干预措施: iron (Diagnostic Test)

RM

Active Comparator

A single intramuscular injection of GLY 50% (10 mL/kg) after 24-h water deprivation and normal saline (4ml/kg) will be administered by gavage.

干预措施: MDA, TAC, and GSH (Diagnostic Test)

RM

Active Comparator

A single intramuscular injection of GLY 50% (10 mL/kg) after 24-h water deprivation and normal saline (4ml/kg) will be administered by gavage.

干预措施: Nrf2 (Diagnostic Test)

RM

Active Comparator

A single intramuscular injection of GLY 50% (10 mL/kg) after 24-h water deprivation and normal saline (4ml/kg) will be administered by gavage.

干预措施: AMPK (Diagnostic Test)

RM

Active Comparator

A single intramuscular injection of GLY 50% (10 mL/kg) after 24-h water deprivation and normal saline (4ml/kg) will be administered by gavage.

干预措施: HO-1 (Diagnostic Test)

RM

Active Comparator

A single intramuscular injection of GLY 50% (10 mL/kg) after 24-h water deprivation and normal saline (4ml/kg) will be administered by gavage.

干预措施: glycerin (Drug)

Lf-RM

Active Comparator

A single intramuscular injection of GLY 50% (10 mL/kg) after 24-h water deprivation and Lf (1000 mg/kg in normal saline, volume 4 mL/kg) will be administered by gavage 30 min. before RM induction

干预措施: Lactoferrin (Drug)

Lf-RM

Active Comparator

A single intramuscular injection of GLY 50% (10 mL/kg) after 24-h water deprivation and Lf (1000 mg/kg in normal saline, volume 4 mL/kg) will be administered by gavage 30 min. before RM induction

干预措施: iron (Diagnostic Test)

Lf-RM

Active Comparator

A single intramuscular injection of GLY 50% (10 mL/kg) after 24-h water deprivation and Lf (1000 mg/kg in normal saline, volume 4 mL/kg) will be administered by gavage 30 min. before RM induction

干预措施: MDA, TAC, and GSH (Diagnostic Test)

Lf-RM

Active Comparator

A single intramuscular injection of GLY 50% (10 mL/kg) after 24-h water deprivation and Lf (1000 mg/kg in normal saline, volume 4 mL/kg) will be administered by gavage 30 min. before RM induction

干预措施: Nrf2 (Diagnostic Test)

Lf-RM

Active Comparator

A single intramuscular injection of GLY 50% (10 mL/kg) after 24-h water deprivation and Lf (1000 mg/kg in normal saline, volume 4 mL/kg) will be administered by gavage 30 min. before RM induction

干预措施: AMPK (Diagnostic Test)

Lf-RM

Active Comparator

A single intramuscular injection of GLY 50% (10 mL/kg) after 24-h water deprivation and Lf (1000 mg/kg in normal saline, volume 4 mL/kg) will be administered by gavage 30 min. before RM induction

干预措施: HO-1 (Diagnostic Test)

Lf-RM

Active Comparator

A single intramuscular injection of GLY 50% (10 mL/kg) after 24-h water deprivation and Lf (1000 mg/kg in normal saline, volume 4 mL/kg) will be administered by gavage 30 min. before RM induction

干预措施: glycerin (Drug)

RM-Lf

Active Comparator

A single intramuscular injection of GLY 50% (10 mL/kg) after 24-h water deprivation and Lf (1000 mg/kg in normal saline, volume 4 mL/kg) will be administered by gavage 30 min. after RM induction.

干预措施: Lactoferrin (Drug)

RM-Lf

Active Comparator

A single intramuscular injection of GLY 50% (10 mL/kg) after 24-h water deprivation and Lf (1000 mg/kg in normal saline, volume 4 mL/kg) will be administered by gavage 30 min. after RM induction.

干预措施: iron (Diagnostic Test)

RM-Lf

Active Comparator

A single intramuscular injection of GLY 50% (10 mL/kg) after 24-h water deprivation and Lf (1000 mg/kg in normal saline, volume 4 mL/kg) will be administered by gavage 30 min. after RM induction.

干预措施: MDA, TAC, and GSH (Diagnostic Test)

RM-Lf

Active Comparator

A single intramuscular injection of GLY 50% (10 mL/kg) after 24-h water deprivation and Lf (1000 mg/kg in normal saline, volume 4 mL/kg) will be administered by gavage 30 min. after RM induction.

干预措施: Nrf2 (Diagnostic Test)

RM-Lf

Active Comparator

A single intramuscular injection of GLY 50% (10 mL/kg) after 24-h water deprivation and Lf (1000 mg/kg in normal saline, volume 4 mL/kg) will be administered by gavage 30 min. after RM induction.

干预措施: AMPK (Diagnostic Test)

RM-Lf

Active Comparator

A single intramuscular injection of GLY 50% (10 mL/kg) after 24-h water deprivation and Lf (1000 mg/kg in normal saline, volume 4 mL/kg) will be administered by gavage 30 min. after RM induction.

干预措施: HO-1 (Diagnostic Test)

RM-Lf

Active Comparator

A single intramuscular injection of GLY 50% (10 mL/kg) after 24-h water deprivation and Lf (1000 mg/kg in normal saline, volume 4 mL/kg) will be administered by gavage 30 min. after RM induction.

干预措施: glycerin (Drug)

结局指标

主要结局

AMPK levels

时间窗: 2 months

AMPK levels in kidney and heart tissue homogenate

HO-1 levels

时间窗: 2 months

HO-1 levels in kidney and heart tissue homogenate

Nrf2 expression

时间窗: 2 months

Nrf2 expression in heart and kidney tissues

次要结局

  • GSH levels(2 months)
  • TAC levels(2 months)
  • MDA levels(2 months)
  • iron levels(2 months)

研究者

发起方
Aswan University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Asmaa Abdel-mageed Muhammed

Lecturer

Aswan University Hospital

研究点 (1)

Loading locations...

相似试验