Effects of Exercise on Patients With Nonalcoholic Fatty Liver Disease- A Comparative Randomized Controlled Trial

Study Overview
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Brief Summary
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background: Obesity, diabetes mellitus type II and fatty liver disease combining with low levels of physical activity are prominent health risks for mortality and morbidity. More than 1/3 of the current population is suffering from obesity with a significant proportion to medical complications which can negatively influence their quality of life. These complications comprise alterations of the metabolism of glucose and fat, insulin resistance and diabetes mellitus. Objectives The purpose of this study was to compare between high intensity interval exercise and moderate intensity continuous on diabetic obese patients with NAFLD. Methods: forty-seven diabetic obese individuals with NAFLD were enrolled in this study. The individuals were randomly divided into 16 in HII group, 15 in MIC group, and 16 in the controls. HII group received HII exercise, MIC group received 8-week MIC exercise while the control group did not receive any exercise intervention. IHTG and visceral lipids were assessed pre- and post-intervention.

Detailed Description
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This randomized controlled trial initially included 48 diabetic obese patients with NAFLD, their age was 40 to 60 years and divide them equally into three groups. The data went to the analysis were 47 due to drop out of one subject. The 47 patients were randomly classified into 3 groups. Group I included 16 patients, received medical treatment with a program of HII exercise 3 times/wk for 8 weeks (HII group), group II included 15 patients, received moderate-intensity continuous (MIC) exercise 3 times/wk for 8 weeks (MIC group), and group III included 16 patients, received only medical treatment without exercise program (control). Inclusion criteria: All patients were diagnosed with NAFLD, type II DM, and obesity (body mass index [BMI] ≥30 kg/m2). The diagnostic criteria of NAFLD based on the diagnostic guidelines for NAFLD in the Asia-Pacific region.[29] All study participants were non-smokers. Exclusion criteria: Any patient had a severe life limiting illness (cancer, renal failure), uncontrolled heart disease, neuromuscular limitations, orthopedic problems, and endocrine disorders that could affect physical exercise was excluded from the study. The HII exercise program was performed on a cycle Ergometer with firmly grasping the rails to maintain balance. The exercise session was started with a 5 minute warm up involving cycling exercise without resistance of the Ergometer followed by three sets of 4-min cycling sessions at 80-85% of the VO2max with 2-min interval at 50% of the VO2max between sets. The session was finished with 5 minutes of cool down exercise. MIC group, each patient was received (MIC 3 times/week) for eight weeks, according to following parameters; 5 minutes warm up, followed by 30 minutes of continuous aerobic exercise on a cycle Ergometer with constant intensity at 70 to 75% of peak HR and 5 minutes cool down. Also, these measures were obtained at the beginning and the end of the intervention.

Official Title
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Effects of High-Intensity Interval and Moderate Intensity Continuous Exercise on Diabetic Obese Patients With Nonalcoholic Fatty Liver Disease- A Comparative Randomized Controlled Trial

Conditions
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Diabetes, Nonalcoholic Fatty Liver Disease, Obesity, Exercise

Intervention / Treatment
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* Other: High-Intensity Interval Exercise & Moderate Intensity Interval Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Clinical diagnosis of NAFLD, type II DM, and obesity. Body mass index (BMI) ≥30 kg/m2. Age: 40-60 years No smoking. Exclusion criteria: Severe life limiting illness (cancer, renal failure), Uncontrolled heart disease, Neuromuscular limitations, Orthopedic problems Endocrine disorders that could affect physical exercise

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study group 1<br>High Intensity Interval Excercise | Other: High-Intensity Interval Exercise & Moderate Intensity Interval Exercise<br>* Different Interval intensities Exercise<br>* Other names: Exercise;|
| Active Comparator: Study group 2<br>Moderate Intensity Interval Exercise | Other: High-Intensity Interval Exercise & Moderate Intensity Interval Exercise<br>* Different Interval intensities Exercise<br>* Other names: Exercise;|
| No Intervention: Control group<br>No Intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intrahepatic triglyceride (%) | Assessment in percentage (%) using MRI with a 3T scanner (General electric, WI) through imaging of chemical shift. Each patient was assessed for imaging in the supine position using the body coil. The patient was instructed to make a single breath hold during imaging, the liver was imaged 3 separate images slice pairs. IHTG proportionate to water was estimated as 100 × (signal amplitude of TG)/(signal amplitude of water). | 8 weeks | 
| Total cholesterol | Total cholesterol, (mg/dL) | 8 weeks | 
| Triglycerides | Triglycerides, (mg/dL) | 8 weeks | 
| High-density lipoproteins (HDLs) | High-density lipoproteins (HDLs), (mg/dL) | 8 weeks | 
| Low-density lipoproteins (LDLs) | Low-density lipoproteins (LDLs), (mg/dL) | 8 weeks | 
| Alanine-transaminase (ALT) | Alanine-transaminase (ALT), (IU/L) | 8 weeks | 
| Hemoglobin A1c (HbA1c) | Hemoglobin A1c (HbA1c), (%) | 8 weeks | 
| Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | It was assessed through Blood Code Calculation: HOMA-IR = Insulin (mU/L) х Glucose (mg/dL). | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Weight (kilograms Kg) Alanine-transaminase (ALT), (IU/L) Visceral adipose fat, (cm2) was assessed by MRI and anthropometric values. Body mass index (BMI) in Kg/m2 was calculated as the weight (in kilograms) divided by height (in meters) squared. | 8 weeks | 
| Height | Height (meters m) | 8 weeks | 
| Body mass index (BMI) | Weight and height were combined to report BMI in kg/m^2 | 8 weeks | 
| Visceral adipose fat | Visceral adipose fat, (cm2) was assessed by MRI and anthropometric values. | 8 weeks |