Non-Alcoholic Fatty Liver Disease, Obesity
Conditions
Keywords
Lifestyle interventions, Low-carbohydrate diet
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.
Interventions
BEHAVIORALLifestyle education
Lifestyle education include the diet principles, physical activity guideline and behavioral strategies.
BEHAVIORALIntensive lifestyle intervention
One to one intensive lifestyle intervention according to the diet and activity plan
BEHAVIORALHypocaloric low-carbohydrate diet plan
A diet plan with restricted calorie and carbohydrate intake
Sponsors
First Affiliated Hospital of Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in BMI | baseline, 3 month | — |
| Change in liver function biomarkers | baseline, 3 month | ALT, AST |
| Liver Stiffness Measurement | baseline, 3 month | LSM is suggested as degree of liver fibrosis |
| Fast Ultrasound Attenuation Parameter | baseline, 3 month | FAP is suggested as degree of liver steatosis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in glycemic markers | baseline, 3 month | fasting glucose, fasting insulin, HbA1C |
| Change in BMI | 6 month, 12 month | — |
| Change in body composition | baseline, 3 month | muscle mass, fat percentage |
| Change in liver function biomarkers | 6 month, 12 month | ALT, AST |
| Change in blood pressure | baseline, 3 month | — |
| Change in lipid | baseline, 3 month | triglyceride, total cholesterol , LDL-C, and HDL-C |
Contacts
Primary ContactZhong Liu
Outcome results
None listed