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NCT Number: NCT03774511

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

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.

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Key information

Conditions

Diabetes Behavior Body Weight Diabetes Mellitus Digestive System Diseases Endocrine System Diseases Exercise Fatty Liver Glucose Metabolism Disorders Liver Diseases Metabolic Diseases Motor Activity Non-alcoholic Fatty Liver Disease Nonalcoholic Fatty Liver Disease Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr Sayed Tanatwy

Giza, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-Intensity Interval Exercise & Moderate Intensity Interval Exercise

Other

Different Interval intensities Exercise

Other names: Exercise

Primary outcomes

  1. Intrahepatic triglyceride (%)

    Time frame: 8 weeks

    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).

  2. Total cholesterol

    Time frame: 8 weeks

    Total cholesterol, (mg/dL)

  3. Triglycerides

    Time frame: 8 weeks

    Triglycerides, (mg/dL)

  4. High-density lipoproteins (HDLs)

    Time frame: 8 weeks

    High-density lipoproteins (HDLs), (mg/dL)

  5. Low-density lipoproteins (LDLs)

    Time frame: 8 weeks

    Low-density lipoproteins (LDLs), (mg/dL)

  6. Alanine-transaminase (ALT)

    Time frame: 8 weeks

    Alanine-transaminase (ALT), (IU/L)

  7. Hemoglobin A1c (HbA1c)

    Time frame: 8 weeks

    Hemoglobin A1c (HbA1c), (%)

  8. Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

    Time frame: 8 weeks

    It was assessed through Blood Code Calculation:

    HOMA-IR = Insulin (mU/L) х Glucose (mg/dL).

Secondary outcomes

  1. Weight

    Time frame: 8 weeks

    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.

  2. Height

    Time frame: 8 weeks

    Height (meters m)

  3. Body mass index (BMI)

    Time frame: 8 weeks

    Weight and height were combined to report BMI in kg/m^2

  4. Visceral adipose fat

    Time frame: 8 weeks

    Visceral adipose fat, (cm2) was assessed by MRI and anthropometric values.

Sponsors and collaborators

Lead sponsor

Ahlia University

Other

Collaborators

  • Cairo University

Registry information

Official study title

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

Acronym: [PTREC]

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 13, 2018
Registry last updated
Jun 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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