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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04550273
Recruitment Status : Recruiting
First Posted : September 16, 2020
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Ali Mohamed Ali ismail, 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.


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.

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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

Resource links provided by the National Library of Medicine


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



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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04550273


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

Locations
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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
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Principal Investigator: Ali Ismail, lecturer Cairo University
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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    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections