Leptin and Liver Enzymes Responses to Aerobic Training in Hepatitis c Patients

Not Applicable

• Conditions: Hepatitis C
• Interventions: Behavioral: aerobic treadmill exercise

• Registration Number: NCT04550273
• Lead Sponsor: Cairo University

Brief Summary

Exercise is one of the most vital components of health maintenance. Exercising regularly maintains the cardiovascular system health, promotes the health of liver, and declines the risks of complications induced by CHCV. Since overweight is the main risk factor for IR and type 2 DM which may speed the liver disease progression among HCV patients, exercise is very important for maintenance and loss of weight. Further, exercise can relieve the side effects of medications of HCV, improve immunity, promote a sense of well-being, reduce levels of chronic fatigue, improve blood oxygen levels and increase the endorphins excretion which makes the patients fully energized (Elgendi, Shebl A, Sliem M, and Gary FA, 2018).

Studies on exercise effect in patients with CHCV are quite scarce (de Sousa Fernandes et al., 2019). Decreased leptin levels by exercise positively modulate insulin signaling and inhibit pathology progression (Anaruma et al., 2019). Since studies investigated physical activity effect on regulating HCV related leptin levels are very little, the present study aimed to explore the response of serum leptin and liver enzymes to aerobic exercise in nondiabetic overweight men with CHCV.

Detailed Description

The study group (n=20) received three sessions of aerobic walking exercise per week for 3 months. Every session was done on an electronic treadmill with no inclination started with 5 minutes warm-up then 30 minutes of moderate-intensity aerobic training with 60-75% of target heart rate then followed or ended by 5 minutes cool down. The control group (n=20) will receive no training.

Study Timeline

• Study Start: 2020-02-09
• Status Verified: 2020-09
• Study First Submitted: 2020-09-09
• Study First Submitted QC: 2020-09-09
• Last Update Submitted: 2020-09-09
• Study First Posted: 2020-09-16
• Last Update Posted: 2020-09-16
• Primary Completion: 2021-01
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• Men with hepatitis C patients at least from 6 months
• BMI ranged ≥ 25 to < 30 kg/m2.
• fasting blood glucose level (FBG) < 100 mg/dl.
• waist circumference < 102 cm.

Exclusion Criteria

• Besides the excluded individuals who participated in any form of physical training in the last 6 months, excluded patients by a physician will be patients with acute or other hepatitis types, cirrhotic or hepatocellular carcinoma, renal or respiratory problems, cardiovascular and neurologic diseases, and hypertension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
study group	aerobic treadmill exercise	The study group (n=20) will receive three sessions of aerobic walking exercise per week for 3 months in addition to the traditional medical treatment

Primary Outcome Measures

Name	Time	Method
Leptin	It will be after 12-week training	It will be measured in plasma
Liver enzymes	liver enzymes will be after 12-week training	Serum alanine and aspartate transaminases (AST), (ALT) will be measured in plasma

Secondary Outcome Measures

Name	Time	Method
weight	It will be after 12-week training	With an empty bladder and stomach, weight will be measured for every participant
Waist circumference (WC)	It will be after 12-week training	WC will be measured with an inelastic tape at the umbilicus level
fasting blood glucose (FBG)	It will be after 12-week training	FBG will be measured by On Call ® Plus Acon, REF G113- 214, made in China

Trial Locations

Locations (1)

Faculty of Physical Therapy Cairo University; 🇪🇬 Giza, Dokki, Egypt