Lactoferrin Effect on Kidney and Heart of Rhabdomyolysis Rats

Phase 4

Not yet recruiting

• Conditions: Rhabdomyolysis
• Interventions: Diagnostic Test: iron; Drug: Lactoferrin; Diagnostic Test: MDA, TAC, and GSH; Diagnostic Test: Nrf2; Diagnostic Test: AMPK; Diagnostic Test: HO-1; Drug: glycerin

• Registration Number: NCT06491394
• Lead Sponsor: Aswan University Hospital

Brief Summary

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?

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-01
• Study First Submitted QC: 2024-07-01
• Study First Posted: 2024-07-09
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-28
• Last Update Posted: 2024-10-01
• Study Start: 2024-11-01
• Primary Completion: 2025-03-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	iron	Normal saline will be administered once to rats intramuscularly (10 mL/kg).
Control	MDA, TAC, and GSH	Normal saline will be administered once to rats intramuscularly (10 mL/kg).
Control	Nrf2	Normal saline will be administered once to rats intramuscularly (10 mL/kg).
Control	AMPK	Normal saline will be administered once to rats intramuscularly (10 mL/kg).
Control	HO-1	Normal saline will be administered once to rats intramuscularly (10 mL/kg).
RM	iron	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.
RM	MDA, TAC, and GSH	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.
RM	Nrf2	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.
RM	AMPK	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.
RM	HO-1	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.
Lf-RM	iron	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
Lf-RM	MDA, TAC, and GSH	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
Lf-RM	Nrf2	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
Lf-RM	AMPK	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
Lf-RM	HO-1	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
RM-Lf	iron	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.
RM-Lf	MDA, TAC, and GSH	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.
RM-Lf	Nrf2	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.
RM-Lf	AMPK	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.
RM-Lf	HO-1	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.
RM	glycerin	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.
Lf-RM	Lactoferrin	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
Lf-RM	glycerin	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
RM-Lf	Lactoferrin	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.
RM-Lf	glycerin	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.

Primary Outcome Measures

Name	Time	Method
AMPK levels	2 months	AMPK levels in kidney and heart tissue homogenate
HO-1 levels	2 months	HO-1 levels in kidney and heart tissue homogenate
Nrf2 expression	2 months	Nrf2 expression in heart and kidney tissues

Secondary Outcome Measures

Name	Time	Method
GSH levels	2 months	GSH levels in heart and kidney tissue homogenate
TAC levels	2 months	TAC levels in heart and kidney tissue homogenate
MDA levels	2 months	MDA levels in heart and kidney tissue homogenate
iron levels	2 months	Iron levels in heart and kidney tissue homogenate