Different Exercise Modalities in the Treatment of NAFLD and Their Impact on Myokines

NAFLD Clinical Trial

Official title:

Investigation of Effectiveness of Different Exercise Types, and Their Therapeutic Effect Mechanisms and the Roles of Motivational Interview in the Treatment of Non-Alcoholic Fatty Liver Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06257732
• Other study ID #: TBTK-MK-2022
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2024
• Est. completion date: October 15, 2024

Study information

• Verified date: January 2024
• Source: Yeditepe University
• Contact: Mehtap Kaçar, MD, PhD, Prof
• Phone: +90 (216) 578 00 00
• Email: mehtap.kacar[@]yeditepe.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this 12-week clinical trial is to investigate the effectiveness of different exercise types in treating Non-Alcoholic Fatty Liver Disease (NAFLD) and to explore their impact on myokine levels associated with lipid metabolism. The main questions it aims to answer are:

1. How does the type and dose of exercise affect the treatment of NAFLD?

2. What is the influence of exercise interventions in NAFLD treatment on myokine levels related to lipid metabolism?

3. How does motivational interviewing contribute to lifestyle modification in the treatment of NAFLD?

Participants in this study will engage in assigned exercise routines randomly, including HIIT, resistance training, or FATmax exercises. Additionally, motivational interviewing techniques will be employed to assess their impact on lifestyle changes. Researchers will compare the outcomes among the different exercise groups, along with a control group receiving only standard care for NAFLD. This comparison aims to determine the respective effects of these interventions on both NAFLD and associated myokine levels.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: October 15, 2024
• Est. primary completion date: September 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

Inclusion Criteria:

• Have received a diagnosis of Non-Alcoholic Fatty Liver Disease (NAFLD)

• Age between 25 and 50 years old

• Use of smartphone

• Fall into category A or B according to the American Heart Association Risk Assessment Criteria

Exclusion Criteria:

• Viral hepatitis

• Excessive alcohol consumption (more than 30 grams per day for men and more than 20 grams per day for women)

• Use of specific medications: amiodarone, corticosteroids, methotrexate, tamoxifen, synthetic estrogen, valproic acid, intravenous tetracycline, and highly active antiretroviral drugs

• Presence of accompanying chronic diseases such as Wilson's disease, hemochromatosis, and celiac disease

• Liver storage diseases

• Cancer

• Cirrhosis

• Advanced changes in liver ultrasonography evaluations, such as fibrosis

• Presence of other chronic diseases (kidney failure, heart failure, atherosclerotic heart disease, hypertension, arrhythmia disorders)

• BMI greater than 40 kg/m²

• History of surgery or trauma in the last 6 months

• Orthopedic and/or neurological impairment

• Health problems that may hinder participation in the exercise program

• Regular and continuous participation in sports or exercise at least 3 times a week for the past 3 years

• Family history of coronary artery disease (coronary artery disease before the age of 45 in male first-degree relatives and other male relatives, or before the age of 65 in female first-degree relatives and other female relatives)

• Presence of specific symptoms during medical history or physical examination: chest pain radiating to the neck, jaw, or arm, shortness of breath during rest or physical activity, dizziness, fainting, orthopnea or paroxysmal nocturnal dyspnea, ankle edema, palpitations or tachycardia, intermittent claudication, heart murmur, unexplained excessive fatigue

• Fall into category C or D according to the American Heart Association Risk Assessment Criteria

Related Conditions & MeSH terms

• Fatty Liver
• Fatty Liver, Nonalcoholic
• Liver Diseases
• NAFLD
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver Disease

Intervention

Other:
• Exercise
The exercise interventions in this study include High-Intensity Interval Training (HIIT), involving brief bursts of intense exercise; Resistance Exercise, focusing on strength and muscle endurance; and Fatmax Exercise, tailored to optimize fat oxidation during aerobic activity.

Behavioral:
• Motivational Interviewing
Motivational Interviewing will be employed as a counseling technique to elicit behavior change by fostering collaborative and empathetic conversations, enhancing motivation for positive lifestyle modifications in individuals with liver fat accumulation.

Locations

Country	Name	City	State
Turkey	Yeditepe University	Istanbul	Atasehir

Sponsors (2)

Lead Sponsor	Collaborator
Yeditepe University	TUBITAK

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the liver steatosis grade	Changes in the level of liver fat accumulation in radiological abdominal ultrasonography (USG) will be observed. The difference between the values obtained at the beginning of the study and those measured after completing the program will be evaluated. Data collected at the beginning and end of the study will be compared.	12-week
Secondary	ALT	The difference between the values obtained at the beginning of the study and those measured after completing the program will be evaluated. Data collected at the beginning and end of the study will be compared.	12-week
Secondary	AST	The difference between the values obtained at the beginning of the study and those measured after completing the program will be evaluated. Data collected at the beginning and end of the study will be compared.	12-week
Secondary	GGT	The difference between the values obtained at the beginning of the study and those measured after completing the program will be evaluated. Data collected at the beginning and end of the study will be compared.	12-week
Secondary	Free fatty acids	The difference between the values obtained at the beginning of the study and those measured after completing the program will be evaluated. Data collected at the beginning and end of the study will be compared.	12-week
Secondary	Triglycerides	The difference between the values obtained at the beginning of the study and those measured after completing the program will be evaluated. Data collected at the beginning and end of the study will be compared.	12-week
Secondary	HDL	The difference between the values obtained at the beginning of the study and those measured after completing the program will be evaluated. Data collected at the beginning and end of the study will be compared.	12-week
Secondary	LDL	The difference between the values obtained at the beginning of the study and those measured after completing the program will be evaluated. Data collected at the beginning and end of the study will be compared.	12-week
Secondary	Total cholesterol	The difference between the values obtained at the beginning of the study and those measured after completing the program will be evaluated. Data collected at the beginning and end of the study will be compared.	12-week
Secondary	CRP	The difference between the values obtained at the beginning of the study and those measured after completing the program will be evaluated. Data collected at the beginning and end of the study will be compared.	12-week
Secondary	ESR	The difference between the values obtained at the beginning of the study and those measured after completing the program will be evaluated. Data collected at the beginning and end of the study will be compared.	12-week
Secondary	Changes in body weight	The difference between the values obtained at the beginning of the study and those measured after completing the program will be evaluated. Data collected at the beginning and end of the study will be compared.	12-week
Secondary	Changes in lean body mass	The difference between the values obtained at the beginning of the study and those measured after completing the program will be evaluated. Data collected at the beginning and end of the study will be compared.	12-week
Secondary	Changes in body fat percentage	The difference between the values obtained at the beginning of the study and those measured after completing the program will be evaluated. Data collected at the beginning and end of the study will be compared.	12-week
Secondary	Changes in body mass index	The difference between the values obtained at the beginning of the study and those measured after completing the program will be evaluated. Data collected at the beginning and end of the study will be compared.	12-week
Secondary	Changes in waist-to-hip ratio	The waist and hip measurements will be taken twice with a tape measure. The results will be aggregated to arrive at one reported value as a waist-to-hip ratio. This is calculated as waist measurement divided by hip measurement (W/H). The difference between the values obtained at the beginning of the study and those measured after completing the program will be evaluated. Data collected at the beginning and end of the study will be compared.	12-week
Secondary	Changes in peak oxygen consumption	At the beginning, every 4 weeks, and at the end of the study, peak oxygen consumption measurement will be conducted through the cardiopulmonary exercise test. Data collected at the beginning and end of the study will be compared.	12-week
Secondary	Changes in peak heart rate	At the beginning, every 4 weeks, and at the end of the study, peak heart rate measurement will be conducted through the cardiopulmonary exercise test. Data collected at the beginning and end of the study will be compared.	12-week
Secondary	Changes in anaerobic threshold	At the beginning, every 4 weeks, and at the end of the study, anaerobic threshold measurements will be conducted through the cardiopulmonary exercise test. Data collected at the beginning and end of the study will be compared.	12-week
Secondary	Changes in basal metabolic rate	Basal metabolic rate measurements will be conducted twice using an indirect calorimeter, once at the beginning and once at the end of the study. Data collected at the beginning and end of the study will be compared.	12-week
Secondary	Changes in muscle strength analysis results	At the beginning and end of the study, the maximum isometric contraction strength of the hand and forearm muscles will be measured using a hand dynamometer. Data collected at the beginning and end of the study will be compared.	12-week
Secondary	Changes in The 5 Times Sit-to-Stand Test results	The 5 Times Sit-to-Stand Test will be administered as a balance test. Data collected at the beginning and end of the study will be compared.	12-week
Secondary	Changes in Single Leg Standing Test results	The Single Leg Standing Test will be administered as a balance test. Data collected at the beginning and end of the study will be compared.	12-week
Secondary	Changes in FATmax levels	At the beginning and end of the study, participants' FATmax levels will be determined through the FATmax test. Data collected at the beginning and end of the study will be compared.	12-week
Secondary	Changes in Healthy Lifestyle Habits Scale II scores	At the beginning and end of the study, a total of two administrations of the questionnaires will be conducted. Data collected at the beginning and end of the study will be compared.	12-week
Secondary	Changes in Short Form Survey (SF-36) scores	At the beginning and end of the study, a total of two administrations of the questionnaires will be conducted. Data collected at the beginning and end of the study will be compared.	12-week
Secondary	Changes in Beck Depression Scale scores	At the beginning and end of the study, a total of two administrations of the questionnaires will be conducted. Data collected at the beginning and end of the study will be compared.	12-week
Secondary	Changes in Pittsburgh Sleep Quality Index scores	At the beginning and end of the study, a total of two administrations of the questionnaires will be conducted. Data collected at the beginning and end of the study will be compared.	12-week
Secondary	Changes in the serum levels of myokines	Serum samples will be obtained twice, at the beginning and end of the study. Musclin, myonectin, and myostatin levels will be measured using ELISA, while measurements of BAIBA will be conducted using Liquid Chromatography Spectrometry. Data collected at the beginning and end of the study will be compared.	12-week