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

NCT03774511 | Completed DMC

• 1 other identifier: P.T. REC/012/002146
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Nonalcoholic Fatty Liver Disease; Obesity; Exercise

Outcome Measures

Primary Outcomes (8)

• 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).

  8 weeks

• Total cholesterol

  Total cholesterol, (mg/dL)

  8 weeks

• Triglycerides

  Triglycerides, (mg/dL)

  8 weeks

• High-density lipoproteins (HDLs)

  High-density lipoproteins (HDLs), (mg/dL)

  8 weeks

• Low-density lipoproteins (LDLs)

  Low-density lipoproteins (LDLs), (mg/dL)

  8 weeks

• Alanine-transaminase (ALT)

  Alanine-transaminase (ALT), (IU/L)

  8 weeks

• Hemoglobin A1c (HbA1c)

  Hemoglobin A1c (HbA1c), (%)

  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).

  8 weeks

Secondary Outcomes (4)

• Weight

  8 weeks

• Height

  8 weeks

• Body mass index (BMI)

  8 weeks

• Visceral adipose fat

  8 weeks

Study Arms (3)

Study group 1

ACTIVE COMPARATOR

High Intensity Interval Excercise

Other: High-Intensity Interval Exercise & Moderate Intensity Interval Exercise

Study group 2

ACTIVE COMPARATOR

Moderate Intensity Interval Exercise

Other: High-Intensity Interval Exercise & Moderate Intensity Interval Exercise

Control group

NO INTERVENTION

No Intervention

Interventions

High-Intensity Interval Exercise & Moderate Intensity Interval Exercise OTHER

Different Interval intensities Exercise

Also known as: Exercise

Study group 1; Study group 2

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical diagnosis of NAFLD, type II DM, and obesity.
• Body mass index (BMI) ≥30 kg/m2.
• Age: 40-60 years
• No smoking.

You may not qualify if:

• Severe life limiting illness (cancer, renal failure),
• Uncontrolled heart disease,
• Neuromuscular limitations,
• Orthopedic problems
• Endocrine disorders that could affect physical exercise

Sponsors & Collaborators

• Ahlia University: lead
• Cairo University: collaborator

Study Sites (1)

Dr Sayed Tanatwy

Giza, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus; Non-alcoholic Fatty Liver Disease; Obesity; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sayed A Tantawy, PhD

  Cairo University, Giza, Egypt

  PRINCIPAL INVESTIGATOR

• Walid K Abdelbasset, PhD

  Cairo University, Giza, Egypt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: December 13, 2018
• Study Start: July 9, 2017
• Primary Completion: August 10, 2018
• Study Completion: December 10, 2018
• Last Updated: June 26, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)