Diabetes[PTREC]NCT03774511
Effects of Exercise on Patients With Nonalcoholic Fatty Liver Disease- A Comparative Randomized Controlled Trial
A study testing High-Intensity Interval Exercise & Moderate Intensity Interval Exercise in people with Diabetes and Nonalcoholic Fatty Liver Disease, run by Ahlia University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Diabetes, Nonalcoholic Fatty Liver Disease, Obesity
- What is being tested?
- High-Intensity Interval Exercise & Moderate Intensity Interval Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Jul 2017to 10 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of NAFLD, type II DM, and obesity.
- Body mass index (BMI) ≥30 kg/m2.
- Age: 40-60 years
- No smoking.
Who cannot join
- Severe life limiting illness (cancer, renal failure),
- Uncontrolled heart disease,
- Neuromuscular limitations,
- Orthopedic problems
- Endocrine disorders that could affect physical exercise
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Diabetes, Nonalcoholic Fatty Liver Disease, Obesity, Exercise
- Being tested
- High-Intensity Interval Exercise & Moderate Intensity Interval Exercise
- Medical subject headings
- Diabetes Mellitus, Non-alcoholic Fatty Liver Disease, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Interval Exercise & Moderate Intensity Interval ExerciseOther
Also called Exercise
Different Interval intensities Exercise
| Study group | Role | What they receive |
|---|---|---|
| Study group 1 | Active comparator | High Intensity Interval Excercise Receives: Other: High-Intensity Interval Exercise & Moderate Intensity Interval Exercise |
| Study group 2 | Active comparator | Moderate Intensity Interval Exercise Receives: Other: High-Intensity Interval Exercise & Moderate Intensity Interval Exercise |
| Control group | No intervention | No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 8 weeks
Total cholesterol
Total cholesterol, (mg/dL)
Measured: 8 weeks
Triglycerides
Triglycerides, (mg/dL)
Measured: 8 weeks
High-density lipoproteins (HDLs)
High-density lipoproteins (HDLs), (mg/dL)
Measured: 8 weeks
Low-density lipoproteins (LDLs)
Low-density lipoproteins (LDLs), (mg/dL)
Measured: 8 weeks
Alanine-transaminase (ALT)
Alanine-transaminase (ALT), (IU/L)
Measured: 8 weeks
Hemoglobin A1c (HbA1c)
Hemoglobin A1c (HbA1c), (%)
Measured: 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).
Measured: 8 weeks
Secondary outcomes (4)
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.
Measured: 8 weeks
Height
Height (meters m)
Measured: 8 weeks
Body mass index (BMI)
Weight and height were combined to report BMI in kg/m^2
Measured: 8 weeks
Visceral adipose fat
Visceral adipose fat, (cm2) was assessed by MRI and anthropometric values.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2018
- Study start9 Jul 2017
- Primary completion10 Aug 2018
- Study completion10 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahlia University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Dr Sayed Tantawy, Ahlia University
- Investigators
- Sayed A Tantawy, PhD, Principal investigator, Cairo University, Giza, EgyptWalid K Abdelbasset, PhD, Study director, Cairo University, Giza, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03774511
- Sponsor's protocol ID
- P.T. REC/012/002146
- Acronym
- [PTREC]
- Status last verified
- Jun 2020
- First submitted
- 12 Dec 2018
- Last updated
- 26 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03774511
- Acronym / sponsor ID
- [PTREC] / P.T. REC/012/002146
- Conditions
- Diabetes, Nonalcoholic Fatty Liver Disease, Obesity, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Ahlia UniversityUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 9 Jul 2017 (actual)
- Primary completion
- 10 Aug 2018 (actual)
- Study completion
- 10 Dec 2018 (actual)
- First posted
- 13 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study group 1 | Active comparator | Other: High-Intensity Interval Exercise & Moderate Intensity Interval ExerciseHigh Intensity Interval Excercise |
| Study group 2 | Active comparator | Other: High-Intensity Interval Exercise & Moderate Intensity Interval ExerciseModerate Intensity Interval Exercise |
| Control group | No intervention | –No Intervention |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of NAFLD, type II DM, and obesity.
- Body mass index (BMI) ≥30 kg/m2.
- Age: 40-60 years
- No smoking.
Key exclusion criteria (5 listed)
- Severe life limiting illness (cancer, renal failure),
- Uncontrolled heart disease,
- Neuromuscular limitations,
- Orthopedic problems
- Endocrine disorders that could affect physical exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Intensity Interval Exercise & Moderate Intensity Interval ExerciseAlso: ExerciseDifferent Interval intensities Exercise | Other | Study group 1, Study group 2 |
Primary outcome
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).
Total cholesterol
Time frame: 8 weeks
Total cholesterol, (mg/dL)
Triglycerides
Time frame: 8 weeks
Triglycerides, (mg/dL)
High-density lipoproteins (HDLs)
Time frame: 8 weeks
High-density lipoproteins (HDLs), (mg/dL)
Low-density lipoproteins (LDLs)
Time frame: 8 weeks
Low-density lipoproteins (LDLs), (mg/dL)
Alanine-transaminase (ALT)
Time frame: 8 weeks
Alanine-transaminase (ALT), (IU/L)
Hemoglobin A1c (HbA1c)
Time frame: 8 weeks
Hemoglobin A1c (HbA1c), (%)
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).
4 secondary outcomes
Weight
Time frame: 8 weeks
Height
Time frame: 8 weeks
Body mass index (BMI)
Time frame: 8 weeks
Visceral adipose fat
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sayed A Tantawy, PhD principal investigator
Cairo University, Giza, Egypt
Walid K Abdelbasset, PhD study director
Cairo University, Giza, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Interval Exercise & Moderate Intensity Interval Exercise in people with Diabetes and Nonalcoholic Fatty Liver Disease, run by Ahlia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intrahepatic triglyceride (%) (time frame: 8 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2020.