<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03774511</url>
  </required_header>
  <id_info>
    <org_study_id>P.T. REC/012/002146</org_study_id>
    <nct_id>NCT03774511</nct_id>
  </id_info>
  <brief_title>Effects of Exercise on Patients With Nonalcoholic Fatty Liver Disease- A Comparative Randomized Controlled Trial</brief_title>
  <acronym>[PTREC]</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ahlia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ahlia University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      background: Obesity, diabetes mellitus type II and fatty liver disease combining with low&#xD;
      levels of physical activity are prominent health risks for mortality and morbidity. More than&#xD;
      1/3 of the current population is suffering from obesity with a significant proportion to&#xD;
      medical complications which can negatively influence their quality of life. These&#xD;
      complications comprise alterations of the metabolism of glucose and fat, insulin resistance&#xD;
      and diabetes mellitus. Objectives The purpose of this study was to compare between high&#xD;
      intensity interval exercise and moderate intensity continuous on diabetic obese patients with&#xD;
      NAFLD. Methods: forty-seven diabetic obese individuals with NAFLD were enrolled in this&#xD;
      study. The individuals were randomly divided into 16 in HII group, 15 in MIC group, and 16 in&#xD;
      the controls. HII group received HII exercise, MIC group received 8-week MIC exercise while&#xD;
      the control group did not receive any exercise intervention. IHTG and visceral lipids were&#xD;
      assessed pre- and post-intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This randomized controlled trial initially included 48 diabetic obese patients with NAFLD,&#xD;
      their age was 40 to 60 years and divide them equally into three groups. The data went to the&#xD;
      analysis were 47 due to drop out of one subject. The 47 patients were randomly classified&#xD;
      into 3 groups. Group I included 16 patients, received medical treatment with a program of HII&#xD;
      exercise 3 times/wk for 8 weeks (HII group), group II included 15 patients, received&#xD;
      moderate-intensity continuous (MIC) exercise 3 times/wk for 8 weeks (MIC group), and group&#xD;
      III included 16 patients, received only medical treatment without exercise program (control).&#xD;
&#xD;
      Inclusion criteria: All patients were diagnosed with NAFLD, type II DM, and obesity (body&#xD;
      mass index [BMI] ≥30 kg/m2). The diagnostic criteria of NAFLD based on the diagnostic&#xD;
      guidelines for NAFLD in the Asia-Pacific region.[29] All study participants were non-smokers.&#xD;
&#xD;
      Exclusion criteria: Any patient had a severe life limiting illness (cancer, renal failure),&#xD;
      uncontrolled heart disease, neuromuscular limitations, orthopedic problems, and endocrine&#xD;
      disorders that could affect physical exercise was excluded from the study.&#xD;
&#xD;
      The HII exercise program was performed on a cycle Ergometer with firmly grasping the rails to&#xD;
      maintain balance. The exercise session was started with a 5 minute warm up involving cycling&#xD;
      exercise without resistance of the Ergometer followed by three sets of 4-min cycling sessions&#xD;
      at 80-85% of the VO2max with 2-min interval at 50% of the VO2max between sets. The session&#xD;
      was finished with 5 minutes of cool down exercise.&#xD;
&#xD;
      MIC group, each patient was received (MIC 3 times/week) for eight weeks, according to&#xD;
      following parameters; 5 minutes warm up, followed by 30 minutes of continuous aerobic&#xD;
      exercise on a cycle Ergometer with constant intensity at 70 to 75% of peak HR and 5 minutes&#xD;
      cool down. Also, these measures were obtained at the beginning and the end of the&#xD;
      intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 9, 2017</start_date>
  <completion_date type="Actual">December 10, 2018</completion_date>
  <primary_completion_date type="Actual">August 10, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <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.&#xD;
Control group only received medical treatment with no exercise intervention</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Intrahepatic triglyceride (%)</measure>
    <time_frame>8 weeks</time_frame>
    <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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total cholesterol</measure>
    <time_frame>8 weeks</time_frame>
    <description>Total cholesterol, (mg/dL)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Triglycerides</measure>
    <time_frame>8 weeks</time_frame>
    <description>Triglycerides, (mg/dL)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>High-density lipoproteins (HDLs)</measure>
    <time_frame>8 weeks</time_frame>
    <description>High-density lipoproteins (HDLs), (mg/dL)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Low-density lipoproteins (LDLs)</measure>
    <time_frame>8 weeks</time_frame>
    <description>Low-density lipoproteins (LDLs), (mg/dL)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Alanine-transaminase (ALT)</measure>
    <time_frame>8 weeks</time_frame>
    <description>Alanine-transaminase (ALT), (IU/L)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hemoglobin A1c (HbA1c)</measure>
    <time_frame>8 weeks</time_frame>
    <description>Hemoglobin A1c (HbA1c), (%)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)</measure>
    <time_frame>8 weeks</time_frame>
    <description>It was assessed through Blood Code Calculation:&#xD;
HOMA-IR = Insulin (mU/L) х Glucose (mg/dL).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>8 weeks</time_frame>
    <description>Weight (kilograms Kg)&#xD;
Alanine-transaminase (ALT), (IU/L)&#xD;
Visceral adipose fat, (cm2) was assessed by MRI and anthropometric values.&#xD;
Body mass index (BMI) in Kg/m2 was calculated as the weight (in kilograms) divided by height (in meters) squared.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height</measure>
    <time_frame>8 weeks</time_frame>
    <description>Height (meters m)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body mass index (BMI)</measure>
    <time_frame>8 weeks</time_frame>
    <description>Weight and height were combined to report BMI in kg/m^2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visceral adipose fat</measure>
    <time_frame>8 weeks</time_frame>
    <description>Visceral adipose fat, (cm2) was assessed by MRI and anthropometric values.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Diabetes</condition>
  <condition>Nonalcoholic Fatty Liver Disease</condition>
  <condition>Obesity</condition>
  <condition>Exercise</condition>
  <arm_group>
    <arm_group_label>Study group 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>High Intensity Interval Excercise</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study group 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Moderate Intensity Interval Exercise</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No Intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High-Intensity Interval Exercise &amp; Moderate Intensity Interval Exercise</intervention_name>
    <description>Different Interval intensities Exercise</description>
    <arm_group_label>Study group 1</arm_group_label>
    <arm_group_label>Study group 2</arm_group_label>
    <other_name>Exercise</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Clinical diagnosis of NAFLD, type II DM, and obesity.&#xD;
&#xD;
          -  Body mass index (BMI) ≥30 kg/m2.&#xD;
&#xD;
          -  Age: 40-60 years&#xD;
&#xD;
          -  No smoking.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Severe life limiting illness (cancer, renal failure),&#xD;
&#xD;
          -  Uncontrolled heart disease,&#xD;
&#xD;
          -  Neuromuscular limitations,&#xD;
&#xD;
          -  Orthopedic problems&#xD;
&#xD;
          -  Endocrine disorders that could affect physical exercise&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sayed A Tantawy, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University, Giza, Egypt</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Walid K Abdelbasset, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Cairo University, Giza, Egypt</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dr Sayed Tanatwy</name>
      <address>
        <city>Giza</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>June 24, 2020</last_update_submitted>
  <last_update_submitted_qc>June 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ahlia University</investigator_affiliation>
    <investigator_full_name>Dr Sayed Tantawy</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>Fatty Liver</mesh_term>
    <mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03774511
org study id: P.T. REC/012/002146
nct id: NCT03774511
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
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
measure: Intrahepatic triglyceride (%)
time frame: 8 weeks
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).
measure: Total cholesterol
time frame: 8 weeks
description: Total cholesterol, (mg/dL)
measure: Triglycerides
time frame: 8 weeks
description: Triglycerides, (mg/dL)
measure: High-density lipoproteins (HDLs)
time frame: 8 weeks
description: High-density lipoproteins (HDLs), (mg/dL)
measure: Low-density lipoproteins (LDLs)
time frame: 8 weeks
description: Low-density lipoproteins (LDLs), (mg/dL)
measure: Alanine-transaminase (ALT)
time frame: 8 weeks
description: Alanine-transaminase (ALT), (IU/L)
measure: Hemoglobin A1c (HbA1c)
time frame: 8 weeks
description: Hemoglobin A1c (HbA1c), (%)
measure: Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
time frame: 8 weeks
description: It was assessed through Blood Code Calculation:
HOMA-IR = Insulin (mU/L) х Glucose (mg/dL).
measure: Weight
time frame: 8 weeks
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.
measure: Height
time frame: 8 weeks
description: Height (meters m)
measure: Body mass index (BMI)
time frame: 8 weeks
description: Weight and height were combined to report BMI in kg/m^2
measure: Visceral adipose fat
time frame: 8 weeks
description: Visceral adipose fat, (cm2) was assessed by MRI and anthropometric values.
arm group label: Study group 1
arm group type: Active Comparator
description: High Intensity Interval Excercise
arm group label: Study group 2
arm group type: Active Comparator
description: Moderate Intensity Interval Exercise
arm group label: Control group
arm group type: No Intervention
description: No Intervention
intervention type: Other
intervention name: High-Intensity Interval Exercise & Moderate Intensity Interval Exercise
description: Different Interval intensities Exercise
arm group label: Study group 1
arm group label: Study group 2
other name: Exercise
criteria: 
gender: All
minimum age: 40 Years
maximum age: 60 Years
healthy volunteers: No
last name: Sayed A Tantawy, PhD
role: Principal Investigator
affiliation: Cairo University, Giza, Egypt
last name: Walid K Abdelbasset, PhD
role: Study Director
affiliation: Cairo University, Giza, Egypt
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ahlia University
investigator full name: Dr Sayed Tantawy
investigator title: Professor
mesh term: Liver Diseases
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease
sharing ipd: No