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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03972631
• Other study ID #: CHPF2018-NALFD-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2019
• Est. completion date: December 2021

Study information

• Verified date: June 2019
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Zhong Liu
• Phone: +86 13957104885
• Email: liuzhongzheyi121[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 292
• Est. completion date: December 2021
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Obesity
• Overweight

Intervention

Behavioral:
• Lifestyle education
Lifestyle education include the diet principles, physical activity guideline and behavioral strategies.
• Intensive lifestyle intervention
One to one intensive lifestyle intervention according to the diet and activity plan
• Hypocaloric low-carbohydrate diet plan
A diet plan with restricted calorie and carbohydrate intake

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in BMI		baseline, 3 month
Primary	Change in liver function biomarkers	ALT, AST	baseline, 3 month
Primary	Liver Stiffness Measurement	LSM is suggested as degree of liver fibrosis	baseline, 3 month
Primary	Fast Ultrasound Attenuation Parameter	FAP is suggested as degree of liver steatosis.	baseline, 3 month
Secondary	Change in BMI		6 month, 12 month
Secondary	Change in liver function biomarkers	ALT, AST	6 month, 12 month
Secondary	Change in blood pressure		baseline, 3 month
Secondary	Change in lipid	triglyceride, total cholesterol , LDL-C, and HDL-C	baseline, 3 month
Secondary	Change in glycemic markers	fasting glucose, fasting insulin, HbA1C	baseline, 3 month
Secondary	Change in body composition	muscle mass, fat percentage	baseline, 3 month