Clinical trial NCT04550273: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatitis C
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 40
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Leptin
timeFrame: It will be after 12-week training
measure: Liver enzymes
timeFrame: liver enzymes will be after 12-week training
Secondary outcomes:
measure: weight
timeFrame: It will be after 12-week training
measure: Waist circumference (WC)
timeFrame: It will be after 12-week training
measure: fasting blood glucose (FBG)
timeFrame: It will be after 12-week training
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy Cairo University
state: Dokki
Study officials:
affiliation: Cairo University
name: Ali Ismail, lecturer
role: PRINCIPAL_INVESTIGATOR
References: