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

• ClinicalTrials.gov Identifier: NCT04550273
• Recruitment Status: Recruiting
• First Posted: September 16, 2020
• Last Update Posted: September 16, 2020
• Sponsor: Cairo University
• Information provided by (Responsible Party): Ali Mohamed Ali ismail, Cairo University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hepatitis C	Behavioral: aerobic treadmill exercise	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: The Effect of Aerobic Exercise on Liver Enzymes in Overweight Prediabetic Patients With Hepatitis c
• Actual Study Start Date: February 9, 2020
• Estimated Primary Completion Date: January 2021
• Estimated Study Completion Date: March 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: study group; 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	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.
No Intervention: control group; The control group (n=20) will receive no training

Outcome Measures

Primary Outcome Measures :

1. Leptin [ Time Frame: It will be after 12-week training ]
   It will be measured in plasma
2. Liver enzymes [ Time Frame: liver enzymes will be after 12-week training ]
   Serum alanine and aspartate transaminases (AST), (ALT) will be measured in plasma

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Gender Eligibility Description: self-representation of gender identity
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Ali Ismail, lecturer; 02 01005154209; allooka2012@gmail.com

Locations

Egypt

Faculty of Physical Therapy Cairo University; Recruiting

Giza, Dokki, Egypt

Contact: Ali Ismail, lecturer 02 01005154209 allooka2012@gmail.com

Sponsors and Collaborators

Cairo University

Investigators

• Principal Investigator: Ali Ismail, lecturer; Cairo University

More Information

• Responsible Party: Ali Mohamed Ali ismail, lecturer of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University, Cairo University
• ClinicalTrials.gov Identifier: NCT04550273
• Other Study ID Numbers: P.T.REC/012/002650
• First Posted: September 16, 2020
• Last Update Posted: September 16, 2020
• Last Verified: September 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Hepatitis A; Hepatitis C; Hepatitis; Liver Diseases; Digestive System Diseases; Hepatitis, Viral, Human; Virus Diseases; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Blood-Borne Infections; Communicable Diseases; Flaviviridae Infections