NCT04772352

Brief Summary

Nonalcoholic fatty liver disease (NAFLD) is the most common and harmful chronic liver disease. NAFLD accounts for 49.3% of the total number of chronic liver disease patients in China. It is important to effectively prevent and control NAFLD and its related diseases. Previous studies show the level of serum uric acid is significantly elevated in patients with NAFLD. Xanthine oxidase is a key enzyme in uric acid metabolism. It is a new therapeutic target for NAFLD. This study is aimed to further confirm that hyperuricemia is a new risk factor for NAFLD through a large sample prospective study. Furthermore, this study explore whether Xanthine oxidase (XO), a key enzyme in uric acid metabolism, plays an important role in regulating NAFLD.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 26, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

February 26, 2021

Status Verified

February 1, 2021

Enrollment Period

5 months

First QC Date

February 23, 2021

Last Update Submit

February 24, 2021

Conditions

Nonalcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (9)

  • Liver fat content of subjects in different groups

    Liver fat was assessed based on Magnetic Resonance Imaging (MRI).

    at the first week.

  • Liver fat content of subjects in different groups

    Liver fat was assessed based on Magnetic Resonance Imaging (MRI).

    at the 24th week .

  • Liver fat content of subjects in different groups

    Liver fat was assessed based on Magnetic Resonance Imaging (MRI).

    at the 48th week.

  • Serum uric acid levels of subjects in different groups

    blood samples was assessed after 12 hours overnight fasting for the determination of hematological and biochemical variables, which were measured using an automated hematology analyzer by standard methods.

    at the first week

  • Serum uric acid levels of subjects in different groups

    blood samples was assessed after 12 hours overnight fasting for the determination of hematological and biochemical variables, which were measured using an automated hematology analyzer by standard methods.

    at the forth week.

  • Serum uric acid levels of subjects in different groups

    blood samples was assessed after 12 hours overnight fasting for the determination of hematological and biochemical variables, which were measured using an automated hematology analyzer by standard methods.

    at the twelfth week.

  • Serum uric acid levels of subjects in different groups

    blood samples was assessed after 12 hours overnight fasting for the determination of hematological and biochemical variables, which were measured using an automated hematology analyzer by standard methods.

    at the 24th week.

  • Serum uric acid levels of subjects in different groups

    blood samples was assessed after 12 hours overnight fasting for the determination of hematological and biochemical variables, which were measured using an automated hematology analyzer by standard methods.

    at the 36th week.

  • Serum uric acid levels of subjects in different groups

    blood samples was assessed after 12 hours overnight fasting for the determination of hematological and biochemical variables, which were measured using an automated hematology analyzer by standard methods.

    at the 48th week.

Study Arms (2)

Experimental group: Lifestyle intervention + febuxostat (40mg, once a day, orally)

EXPERIMENTAL

participants accept febuxostat treatment in addition to lifestyle intervention for 0-48 week.

Drug: febuxostat treatmentBehavioral: lifestyle intervention

Control group: Lifestyle intervention

ACTIVE COMPARATOR

participants receive lifestyle intervention for 0-24 week. If the results of the 0-24 week study showed that the liver fat content of subjects in the experimental group was significantly lower than that in the control group, control group will accept febuxostat treatment in addition to lifestyle intervention in the next 25-48 week.

Behavioral: lifestyle intervention

Interventions

febuxostat treatmentDRUG

According to NAFLD guidelines, participants accept febuxostat treatment (40mg, once a day, orally)

Experimental group: Lifestyle intervention + febuxostat (40mg, once a day, orally)
lifestyle interventionBEHAVIORAL

According to NAFLD guidelines, participants receive lifestyle intervention (diet and exercise).

Control group: Lifestyle interventionExperimental group: Lifestyle intervention + febuxostat (40mg, once a day, orally)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • with informed consent;
  • Ages 18-65;
  • Overweight/obesity: BMI ≥24kg/m2;
  • A history of gout with serum uric acid levels of \> 420μmol/L in men and postmenopausal women, and \>360 μmol/L in premenopausal women;
  • Moderate or above fatty liver was found in the initial screening by ultrasound, and the liver fat content was more than 15% as determined by MRI-PDFF.

You may not qualify if:

  • with a history of allergy to febuxostat and allopurinol;
  • in the acute active phase of gout;
  • Drinking equivalent to alcohol intake ≥30g/d(male), ≥20g/d(female);
  • Patients with obvious abnormal liver function: serum transaminase (ALT, AST, GGT one of them) or serum bilirubin (direct bilirubin, indirect bilirubin one of them) exceed 2 times the upper limit of normal reference value; Serum albumin \<35g/L;
  • Have a history of viral hepatitis, or serological examination suggests hepatitis virus infection, or have a history of other liver diseases;
  • Complicated with renal insufficiency (SCr \>133μmol/L) or urinary protein +;
  • Complicated coronary heart disease;
  • Cardiac dysfunction (cardiac function grade 2 or above);
  • Complementation with diabetes, or fasting blood glucose \>7.8mmol/L, or HbA1c \>7.5%;
  • Severe hypertension, blood pressure ≥ 160/100 mmHg;
  • Patients with asthma and other respiratory diseases;
  • Intestinal diseases such as inflammatory bowel disease;
  • Any history of systemic malignancy in the past 5 years;
  • Morbid obesity (BMI\>37.5kg/m2);
  • Triglyceride ≥5.0 mmol/L was found to be significantly abnormal in baseline examination;
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ningbo first hospital

Ningbo, Zhejiang, 315000, China

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A total of 200 subjects are enrolled in this study. After the initial screening, the subjects were randomly divided into the control group and the drug treatment group. The control group was given lifestyle intervention at 0-24 weeks, and the experimental group was given febuxostat oral therapy on the basis of lifestyle intervention. If the results showed that the reduction of liver fat content of subjects in the lifestyle intervention combined with febuxostat treatment group was significantly better than that in the lifestyle intervention group alone, the original intervention was continued in the drug treatment group, and the control group was given febuxostat orally on the basis of the lifestyle intervention at 24-48 weeks.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2021

First Posted

February 26, 2021

Study Start

March 1, 2021

Primary Completion

August 1, 2021

Study Completion

March 1, 2022

Last Updated

February 26, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)