Leptin and Liver Enzymes Responses to Aerobic Training in Hepatitis c Patients
Primary Purpose
Hepatitis C
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
aerobic treadmill exercise
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C
Eligibility 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
Sites / Locations
- Faculty of Physical Therapy Cairo UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
study group
control group
Arm Description
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
The control group (n=20) will receive no training
Outcomes
Primary Outcome Measures
Leptin
It will be measured in plasma
Liver enzymes
Serum alanine and aspartate transaminases (AST), (ALT) will be measured in plasma
Secondary Outcome Measures
weight
With an empty bladder and stomach, weight will be measured for every participant
Waist circumference (WC)
WC will be measured with an inelastic tape at the umbilicus level
fasting blood glucose (FBG)
FBG will be measured by On Call ® Plus Acon, REF G113- 214, made in China
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04550273
Brief Title
Leptin and Liver Enzymes Responses to Aerobic Training in Hepatitis c Patients
Official Title
The Effect of Aerobic Exercise on Liver Enzymes in Overweight Prediabetic Patients With Hepatitis c
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 9, 2020 (Actual)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
March 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Experimental
Arm Description
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
Arm Title
control group
Arm Type
No Intervention
Arm Description
The control group (n=20) will receive no training
Intervention Type
Behavioral
Intervention Name(s)
aerobic treadmill exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Leptin
Description
It will be measured in plasma
Time Frame
It will be after 12-week training
Title
Liver enzymes
Description
Serum alanine and aspartate transaminases (AST), (ALT) will be measured in plasma
Time Frame
liver enzymes will be after 12-week training
Secondary Outcome Measure Information:
Title
weight
Description
With an empty bladder and stomach, weight will be measured for every participant
Time Frame
It will be after 12-week training
Title
Waist circumference (WC)
Description
WC will be measured with an inelastic tape at the umbilicus level
Time Frame
It will be after 12-week training
Title
fasting blood glucose (FBG)
Description
FBG will be measured by On Call ® Plus Acon, REF G113- 214, made in China
Time Frame
It will be after 12-week training
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
self-representation of gender identity
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Ismail, lecturer
Phone
02 01005154209
Email
allooka2012@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Ismail, lecturer
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physical Therapy Cairo University
City
Giza
State/Province
Dokki
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Ismail, lecturer
Phone
02 01005154209
Email
allooka2012@gmail.com
12. IPD Sharing Statement
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Leptin and Liver Enzymes Responses to Aerobic Training in Hepatitis c Patients
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