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

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ClinicalTrials.gov Identifier: NCT03774511
Recruitment Status : Completed
First Posted : December 13, 2018
Last Update Posted : June 26, 2020
Sponsor:
Collaborator:
Cairo University
Information provided by (Responsible Party):
Dr Sayed Tantawy, Ahlia University

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.

Condition or disease Intervention/treatment Phase
Diabetes Nonalcoholic Fatty Liver Disease Obesity Exercise Other: High-Intensity Interval Exercise & Moderate Intensity Interval Exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes 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

Primary Purpose: Treatment
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
Actual Study Start Date : July 9, 2017
Actual Primary Completion Date : August 10, 2018
Actual Study Completion Date : December 10, 2018


Arm Intervention/treatment
Active Comparator: Study group 1
High Intensity Interval Excercise
Other: High-Intensity Interval Exercise & Moderate Intensity Interval Exercise
Different Interval intensities Exercise
Other Name: Exercise

Active Comparator: Study group 2
Moderate Intensity Interval Exercise
Other: High-Intensity Interval Exercise & Moderate Intensity Interval Exercise
Different Interval intensities Exercise
Other Name: Exercise

No Intervention: Control group
No Intervention



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774511


Locations
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Egypt
Dr Sayed Tanatwy
Giza, Egypt
Sponsors and Collaborators
Ahlia University
Cairo University
Investigators
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Principal Investigator: Sayed A Tantawy, PhD Cairo University, Giza, Egypt
Study Director: Walid K Abdelbasset, PhD Cairo University, Giza, Egypt
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Responsible Party: Dr Sayed Tantawy, Professor, Ahlia University
ClinicalTrials.gov Identifier: NCT03774511    
Other Study ID Numbers: P.T. REC/012/002146
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: June 26, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases