Clinical trial NCT03774511: Effects of Exercise on Patients With Nonalcoholic Fatty Liver Disease- A Comparative Randomized Controlled Trial
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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Nonalcoholic Fatty Liver Disease
Obesity
Exercise
Lead sponsor: Ahlia University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2018-12-13
Enrollment: 48
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Intrahepatic triglyceride (%)
timeFrame: 8 weeks
measure: Total cholesterol
timeFrame: 8 weeks
measure: Triglycerides
timeFrame: 8 weeks
measure: High-density lipoproteins (HDLs)
timeFrame: 8 weeks
measure: Low-density lipoproteins (LDLs)
timeFrame: 8 weeks
measure: Alanine-transaminase (ALT)
timeFrame: 8 weeks
measure: Hemoglobin A1c (HbA1c)
timeFrame: 8 weeks
measure: Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
timeFrame: 8 weeks
Secondary outcomes:
measure: Weight
timeFrame: 8 weeks
measure: Height
timeFrame: 8 weeks
measure: Body mass index (BMI)
timeFrame: 8 weeks
measure: Visceral adipose fat
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Dr Sayed Tanatwy
Study officials:
affiliation: Cairo University, Giza, Egypt
name: Sayed A Tantawy, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University, Giza, Egypt
name: Walid K Abdelbasset, PhD
role: STUDY_DIRECTOR
References: