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An Exercise Intervention Study In NAFLD Patients

An Exercise Intervention Study In NAFLD Patients - CRISTINA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON49148
Enrollment
30
Registered
2019-07-30
Start date
2019-11-21
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-alcoholic fatty liver disease

Interventions

The participants will follow the 12-week exercise intervention with specified instructions according to the study group. HIIT group will receive structions for high-intensity aerobic interval traini

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Diagnosis of steatosis on transient elastography, conventional ultrasound, magnetic resonance imaging, computed tomography , or by liver biopsy, or identified as steatotic subject by fatty liver index (FLI) algorithm which is based on waist circumference, body mass index, and levels of triglyceride and γ- glutamyltransferase. - 18-70 years of age - BMI

Exclusion criteria

Exclusion criteria: - Acute illness or current evidence of acute or chronic inflammatory or infective diseases - Abusive alcohol use (> 21 IU/week for men, > 14 IU/week for women) - Diagnosed liver cirrhosis and/or hepatocellular carcinoma - Diagnosed cardiorespiratory, neurological or musculoskeletal disease - Diagnosed insulin or GLP-1 agonist treated type 2 diabetes or type 1 diabetes - Hepatitis B and/or C or auto-immune hepatitis - Wilsons disease/ alpha-1-antitripsine deficiency - Hemochromatosis - Untreated hypothyroidism - Lipoatrophy - Bleeding disorder or anti-coagulant use which cannot be temporarily discontinued - Not able or willing to undergo MRI (for example claustrophobia, ICD, pacemaker) - Diagnosed depression or any mental illness rendering the patients unable to understand the nature, scope and possible sequences of the study - Any participation in regular exercise and/or diet program more than 2 times per week in the 3 months prior to recruitment

Design outcomes

Primary

MeasureTime frame
- NAFL disease progression compared between baseline and after 12 weeks intervention, evaluated by liver biopsy and MRI/MRS scan. This is based on analysis between baseline and endpoint. - Hepatic, muscle and adipose tissue histology and gene expression (evaluated by RNA-sequencing) that is affected by exercise intervention. This is based on liver, muscle and adipose tissue biopsy at baseline and endpoint.

Secondary

MeasureTime frame
- Fecal microbial composition variation, evaluated by metagenomic sequencing. This is based on fecal sample at baseline, midway, and endpoint. - Metabolite quantification of plasma and urine samples. This is based on urine samples at baseline and endpoint, and blood samples at baseline, midway and endpoint.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)