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

Primary Purpose

Diabetes, Nonalcoholic Fatty Liver Disease, Obesity

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
High-Intensity Interval Exercise & Moderate Intensity Interval Exercise
Sponsored by
Ahlia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dr Sayed Tanatwy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Study group 1

Study group 2

Control group

Arm Description

High Intensity Interval Excercise

Moderate Intensity Interval Exercise

No Intervention

Outcomes

Primary Outcome Measures

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).
Total cholesterol
Total cholesterol, (mg/dL)
Triglycerides
Triglycerides, (mg/dL)
High-density lipoproteins (HDLs)
High-density lipoproteins (HDLs), (mg/dL)
Low-density lipoproteins (LDLs)
Low-density lipoproteins (LDLs), (mg/dL)
Alanine-transaminase (ALT)
Alanine-transaminase (ALT), (IU/L)
Hemoglobin A1c (HbA1c)
Hemoglobin A1c (HbA1c), (%)
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
It was assessed through Blood Code Calculation: HOMA-IR = Insulin (mU/L) х Glucose (mg/dL).

Secondary Outcome Measures

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.
Height
Height (meters m)
Body mass index (BMI)
Weight and height were combined to report BMI in kg/m^2
Visceral adipose fat
Visceral adipose fat, (cm2) was assessed by MRI and anthropometric values.

Full Information

First Posted
December 12, 2018
Last Updated
June 24, 2020
Sponsor
Ahlia University
Collaborators
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03774511
Brief Title
Effects of Exercise on Patients With Nonalcoholic Fatty Liver Disease- A Comparative Randomized Controlled Trial
Acronym
[PTREC]
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
July 9, 2017 (Actual)
Primary Completion Date
August 10, 2018 (Actual)
Study Completion Date
December 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ahlia University
Collaborators
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Nonalcoholic Fatty Liver Disease, Obesity, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
HII group, each patient in this group were conducted a program of high-intensity aerobic exercise for 8 weeks, three times per week with each exercise session lasting for nearly 40 minutes morning. Each patient was instructed to not eat for 2 hours before the exercise session to avoid exercise induced airway obstruction. 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. Control group only received medical treatment with no exercise intervention
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group 1
Arm Type
Active Comparator
Arm Description
High Intensity Interval Excercise
Arm Title
Study group 2
Arm Type
Active Comparator
Arm Description
Moderate Intensity Interval Exercise
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No Intervention
Intervention Type
Other
Intervention Name(s)
High-Intensity Interval Exercise & Moderate Intensity Interval Exercise
Other Intervention Name(s)
Exercise
Intervention Description
Different Interval intensities Exercise
Primary Outcome Measure Information:
Title
Intrahepatic triglyceride (%)
Description
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).
Time Frame
8 weeks
Title
Total cholesterol
Description
Total cholesterol, (mg/dL)
Time Frame
8 weeks
Title
Triglycerides
Description
Triglycerides, (mg/dL)
Time Frame
8 weeks
Title
High-density lipoproteins (HDLs)
Description
High-density lipoproteins (HDLs), (mg/dL)
Time Frame
8 weeks
Title
Low-density lipoproteins (LDLs)
Description
Low-density lipoproteins (LDLs), (mg/dL)
Time Frame
8 weeks
Title
Alanine-transaminase (ALT)
Description
Alanine-transaminase (ALT), (IU/L)
Time Frame
8 weeks
Title
Hemoglobin A1c (HbA1c)
Description
Hemoglobin A1c (HbA1c), (%)
Time Frame
8 weeks
Title
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Description
It was assessed through Blood Code Calculation: HOMA-IR = Insulin (mU/L) х Glucose (mg/dL).
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Weight
Description
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.
Time Frame
8 weeks
Title
Height
Description
Height (meters m)
Time Frame
8 weeks
Title
Body mass index (BMI)
Description
Weight and height were combined to report BMI in kg/m^2
Time Frame
8 weeks
Title
Visceral adipose fat
Description
Visceral adipose fat, (cm2) was assessed by MRI and anthropometric values.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sayed A Tantawy, PhD
Organizational Affiliation
Cairo University, Giza, Egypt
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Walid K Abdelbasset, PhD
Organizational Affiliation
Cairo University, Giza, Egypt
Official's Role
Study Director
Facility Information:
Facility Name
Dr Sayed Tanatwy
City
Giza
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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

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