Effects of Exercise on Patients With Nonalcoholic Fatty Liver Disease- A Comparative Randomized Controlled Trial ([PTREC])

Effects of High-Intensity Interval and Moderate Intensity Continuous Exercise on Diabetic Obese 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.

Study Overview

• Status: Completed
• Conditions: Obesity; Diabetes; Exercise; Nonalcoholic Fatty Liver Disease
• Intervention / Treatment: Other: High-Intensity Interval Exercise & Moderate Intensity Interval Exercise

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Dr Sayed Tanatwy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; No Intervention
Active Comparator: Study group 1; High Intensity Interval Excercise	Other: High-Intensity Interval Exercise & Moderate Intensity Interval Exercise; Different Interval intensities Exercise; Other Names: Exercise
Active Comparator: Study group 2; Moderate Intensity Interval Exercise	Other: High-Intensity Interval Exercise & Moderate Intensity Interval Exercise; Different Interval intensities Exercise; Other Names: Exercise

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ahlia University
• Collaborators: Cairo University
• Investigators: Principal Investigator: Sayed A Tantawy, PhD, Cairo University, Giza, Egypt; Study Director: Walid K Abdelbasset, PhD, Cairo University, Giza, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2017
• Primary Completion (Actual): August 10, 2018
• Study Completion (Actual): December 10, 2018

Study Registration Dates

• First Submitted: December 12, 2018
• First Submitted That Met QC Criteria: December 12, 2018
• First Posted (Actual): December 13, 2018

Study Record Updates

• Last Update Posted (Actual): June 26, 2020
• Last Update Submitted That Met QC Criteria: June 24, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: P.T. REC/012/002146

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No