Lifestyle Interventions for the Treatment of Non-alcoholic Fatty Liver Disease in Overweight and Obese Adults

Not Applicable

• Conditions: Obesity; Non-Alcoholic Fatty Liver Disease

• Registration Number: NCT03972631
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

Brief Summary

Lifestyle intervention is the most important management of non-alcoholic fatty liver diseases (NAFLD) patients. Weight reductions of 5-10% can improve non-alcoholic steatosis and fibrosis. However, the options for treatment in the clinics are limited. Therefore, in this study, we investigated the effectiveness of different lifestyle intervention strategies in NAFLD patients.

Detailed Description

This is a multicenter, randomized clinical trial nested within a cohort study in overweight and obese non-alcoholic fatty liver diseases (NAFLD) patients. In this study, 1500 eligible patients will be recruited, and demographic information and clinical data will be collected at baseline. Among these, 292 participants who agree to be randomized will be randomized into two intervention groups, including lifestyle education (LE), and intensive lifestyle intervention with low-carbohydrate diet (ILI), aiming to induce a loss ≥ 10% of initial weight in 3 months. The remainder will chose the treatment which they prefer according to the clinical practice. At the 3th, 6th and 12th month, all the participants will be followed, and data will be collected to study the development of NAFLD in different lifestyle intervention groups.

Study Timeline

• Study First Submitted: 2019-05-31
• Study First Submitted QC: 2019-05-31
• Status Verified: 2019-06
• Study First Posted: 2019-06-03
• Last Update Submitted: 2019-06-11
• Last Update Posted: 2019-06-13
• Study Start: 2019-07
• Primary Completion: 2020-04
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 292

Inclusion Criteria

• Man or women aged 18-65 years;
• Confirmed diagnosis of NAFLD according to the 2018 Chinese Guidelines for Prevention and Treatment of NAFLD;
• Body mass index (BMI)of 25.0 to 35.0 kg/m2;
• Patients without medicine for treatment of NAFLD;

Exclusion Criteria

• Patients with other diseases that can lead to fatty liver;
• Patients use amiodaron, methotrexate, tamoxifen, glucocorticoid, estrogen, and the other medications that affect weight within 3 months;
• Patients with serious liver dysfunction (AST or/and ALT >3 times of the upper limit of normal), or renal dysfunction (serum creatinine >the upper limit of normal);
• Patients with diseases that need control of dietary protein intake;
• Patients with diseases that affect food digestion and absorption;
• Patients with diagnosed diabetes or those with significantly elevated blood glucose (fasting blood glucose ≥7.0 mmol/L and/or random blood glucose ≥11.1 mmol/L);
• Patients with severe cardiovascular and cerebrovascular diseases or severe hypertension (Grade 3); anemia; mental illness or memory disorder; epilepsy or antiepileptic treatment;
• Patients with secondary obesity;
• Patients with cancer, active tuberculosis, AIDS and other infectious diseases;
• Pregnancy or lactation;
• Physical disability.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Liver Stiffness Measurement	baseline, 3 month	LSM is suggested as degree of liver fibrosis
Change in BMI	baseline, 3 month
Fast Ultrasound Attenuation Parameter	baseline, 3 month	FAP is suggested as degree of liver steatosis.
Change in liver function biomarkers	baseline, 3 month	ALT, AST

Secondary Outcome Measures

Name	Time	Method
Change in glycemic markers	baseline, 3 month	fasting glucose, fasting insulin, HbA1C
Change in body composition	baseline, 3 month	muscle mass, fat percentage
Change in BMI	6 month, 12 month
Change in blood pressure	baseline, 3 month
Change in liver function biomarkers	6 month, 12 month	ALT, AST
Change in lipid	baseline, 3 month	triglyceride, total cholesterol , LDL-C, and HDL-C