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

Hepatitis C Clinical Trial

Official title:

The Effect of Aerobic Exercise on Liver Enzymes in Overweight Prediabetic Patients With Hepatitis c

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04550273
• Other study ID #: P.T.REC/012/002650
• Status: Recruiting
• Phase: N/A
• Start date: February 9, 2020
• Est. completion date: March 2021

Study information

• Verified date: September 2020
• Source: Cairo University
• Contact: Ali Ismail, lecturer
• Phone: 02 01005154209
• Email: allooka2012[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Behavioral:
• aerobic treadmill exercise
The study group (n=20) received three sessions of aerobic 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.

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy Cairo University	Giza	Dokki

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Leptin	It will be measured in plasma	It will be after 12-week training
Primary	Liver enzymes	Serum alanine and aspartate transaminases (AST), (ALT) will be measured in plasma	liver enzymes will be after 12-week training
Secondary	weight	With an empty bladder and stomach, weight will be measured for every participant	It will be after 12-week training
Secondary	Waist circumference (WC)	WC will be measured with an inelastic tape at the umbilicus level	It will be after 12-week training
Secondary	fasting blood glucose (FBG)	FBG will be measured by On Call ® Plus Acon, REF G113- 214, made in China	It will be after 12-week training