Clinical Trials Logo

Clinical Trial Summary

Nonalcoholic fatty liver disease (NAFLD) is the leading cause of chronic liver disease in the United States. The most advanced forms of NAFLD are associated with increased liver-related mortality and lower overall survival. The current standard of care for NAFLD is lifestyle changes through diet and exercise. The human genome and regulation of gene expression is influenced by physical activity. NAFLD is a prothrombotic state with derangements in all three phases of hemostasis leading to clinically important clotting events. Exercise can improve coagulation in healthy persons. In this proposal, we seek to begin a line of work to answer the question "Can lifestyle changes effectively mitigate the increased risk of clotting in patients with NAFLD?" focusing initially on the at-risk population genetically susceptible to advanced disease.


Clinical Trial Description

Often comorbid with obesity, nonalcoholic fatty liver disease (NAFLD) is the leading cause of chronic liver disease in the United States affecting 75-100 million adults, of which 15-20 million have the more severe variant nonalcoholic steatohepatitis (NASH). Conservative estimates project a doubling in NASH by 2025.The most advanced forms of NAFLD are associated with increased liver-related mortality and lower overall survival. The most effective treatment for NAFLD remains adopting healthy dietary and exercise patterns, however NAFLD patients are among the least physically active individuals. Predicting exercise behavior on an individual level is highly complex due to differing motivation, physiologic response to and subjective experience of exercise as well as emerging genetic evidence. The human genome and regulation of gene expression is influenced by physical activity. Patatin like phospholipase-3 (PNPLA3) rs738409 polymorphism (GG, GC and CC genotypes) plays a crucial role in the development of NAFLD. The GG genotype is both associated with advanced NAFLD, and predicts response to physical activity. Patients with NASH have extensive extrahepatic disease and are hypercoagulable. NASH is a prothrombotic state with fibrinolytic dysfunction through elevated plasminogen activator inhibitor (PAI-1), an independent risk factor for venous thromboembolism (VTE). Consequently, patients with NASH are predisposed to VTE; the risk of portal vein thrombosis (PVT) in NASH is 210% greater than in other liver disease. NASH patients are also at increased risk for pulmonary embolism (PE) and deep vein thrombosis (DVT).The most advanced forms of NASH have the greatest thrombotic risk. While studies observe that change in diet, weight and physical activity patterns improve NASH, it is not clear whether these lifestyle changes also reduce the elevated clot risk, however, moderate-intensity exercise leads to improved fibrinolysis in healthy persons.The NASHFit study is being done to find out if exercise is beneficial in decreasing the risk of clotting problems in patients with NASH. Exercise has been shown to decrease markers of clotting in healthy individuals as well as in those with cardiovascular disease. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03518294
Study type Interventional
Source Milton S. Hershey Medical Center
Contact
Status Completed
Phase N/A
Start date June 1, 2018
Completion date March 24, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT05255042 - Tissue Models for Liver Disease
Completed NCT04473482 - Michigan Alcohol Improvement Network- Alcohol Reduction and Treatment Trial N/A
Not yet recruiting NCT05120557 - Point-of-care Ultrasound Screening and Assessment of Chronic Liver Diseases and NASH N/A
Completed NCT02917408 - Retrospective Study About Primary Biliary Cholangitis During January 2001 to July 2016 at West China Hospital
Recruiting NCT03773887 - Comparison of Inflammatory Profiles and Regenerative Potential in Alcoholic Liver Disease N/A
Recruiting NCT00345930 - DILIN's Prospective Study
Completed NCT00148031 - Improving Hepatitis C Treatment in Injection Drug Users Phase 4
Terminated NCT00031135 - Total Parenteral Nutrition-Associated Liver Disease Phase 2
Completed NCT00005305 - Hepatitis Delta Infections in Hemophiliacs N/A
Completed NCT00005304 - Delta Hepatitis and Liver Disease in Hemophiliacs
Completed NCT00222664 - Qidong Hepatitis B Intervention Study Phase 4
Recruiting NCT06195917 - Robotic-assisted Percutaneous Transhepatic Puncture N/A
Recruiting NCT04551742 - Social & Contextual Impact on Children Undergoing Liver Transplantation
Completed NCT04782050 - Non-invasive Ultrasound Diagnosis of Chronic Liver Diseases in Hepatology Consultation N/A
Completed NCT03614039 - Effect of Probiotic and Smectite Gel on NAFLD N/A
Recruiting NCT04518852 - TACE, Sorafenib and PD-1 Monoclonal Antibody in the Treatment of HCC Phase 2
Recruiting NCT05499585 - Treating Pediatric NAFLD With Nutrition N/A
Terminated NCT03396705 - Liver Regeneration
Completed NCT04341012 - Breath Analysis Based Disease Biomarkers of COVID-19 and Other Diseases
Recruiting NCT05733832 - A Trial of Post-Discharge Transitional Care for Patients With Chronic Liver Disease N/A