A prospective single-center study to evaluate the feasibility of motivation management by wearable fitness devices and smart phone application to influence the clinical manifestation of non-alcoholic fatty liver disease (NAFLD) (OCUN-1)

Not Applicable

Recruiting

• Conditions: on-alcoholic fatty liver disease (NAFLD)

• Registration Number: JPRN-UMIN000035430
• Lead Sponsor: Department of Hepatology, Graduate School of Medicine, Osaka City Universit.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-01
• Study Completion: 2021-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

1. HCV antibody and HBs antigen positive patients. 2. Patients who screened ANA, AMA-M2 antibody, IgG, IgM, etc. and autoimmune diseases (autoimmune hepatitis, primary biliary cholangitis, etc.) can not be excluded. 3. Patient with drug-induced liver injury. 4. Patients with metabolic liver disease (hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency etc.) 5. Patients with severe heart disease (unstable angina, acute heart failure, severe valvular disease, severe arrhythmia, active myocarditis, moderate aortic aneurysm, severe hypertension and thrombophlebitis). 6. Patients with acute systemic disease or fever. 7. Patients with severe cirrhosis (Child-Pugh score B or C). 8. Patients with severe kidney disease (BUN 25 mg / dL or more or serum creatinine 2.0 mg / dL or more). 9. Patients who judged unsuitable as subjects by doctors.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change rate of controlled attenuation parameter (CAP) by Fibroscan 4 months after starting the test.

Secondary Outcome Measures

Name	Time	Method
1. Change rate of ALT value and insulin resistance (HOMA-IR) 4 months after the start of the test. 2. Change rate of adipocytokine (TNF-alpha, leptin, adiponectin) and myoctane (irisin, myostatin, follistatin) 4 months after the start of the test. 3. Change rate of body weight, body fat composition, and hepatic elasticity. 4. Change rate of FIB-4 index, 4 type collagen 7S, CK-18 fragment, and pro-C3 4 months after starting the test. 5. Achievement of diet and exercise therapy. 6. The rate of change between the continuation group and the discontinuation group at the time of the follow-up inspection of each factor of 1-5.