Liver Diseases Clinical Trial
Official title:
NASH Fitness Intervention in Thrombosis Trial (NASHFit)
NCT number | NCT03518294 |
Other study ID # | 8507 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2018 |
Est. completion date | March 24, 2021 |
Verified date | January 2023 |
Source | Milton S. Hershey Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 28 |
Est. completion date | March 24, 2021 |
Est. primary completion date | March 24, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria Adults age >=18 or <70 years Liver biopsy <= 6months prior to enrollment Biopsy proven NASH(79) Lack of secondary causes of hepatic fat accumulation: Significant alcohol consumption (<21 drinks/week for men and <14 drinks/week for women) Chronic hepatitis C Wilson disease Lipodystrophy Parenteral nutrition Long-term use of steatogenic medications (mipomersen, lomitapide, amiodarone, methotrexate, tamoxifen, corticosteroids) Monogenic hereditary disorders Exclusion Criteria >90 minutes/week of at least moderate intensity exercise over the previous three months Pregnancy BMI <18 or >40 kg/m2(16) Uncontrolled diabetes (changes in medication dosing over the previous three months or hemoglobin A1c >9%)(12) Active cardiac symptoms Severe medical comorbidities/psychiatric illness Decompensated cirrhosis (history of esophageal varices, ascites or hepatic encephalopathy) Abdominal hernia Cancer with life expectancy <6 months MRI contraindications (severe claustrophobia, implanted ferrous metal) Other liver disease (positive hepatitis B surface antigen, antinuclear antibody titer >1:160) Active weight-loss program participation or weight-loss supplement use Active substance abuse/smoking Inability to provide informed consent Institutionalized/prisoner Inability to walk > 2 blocks or ΒΌ mile. Physical Activity Readiness Questionnaire (PAR-Q) score >=1 at the discretion of the study PI |
Country | Name | City | State |
---|---|---|---|
United States | Penn State Hershey Medical Center | Hershey | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Milton S. Hershey Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PAI-1 Level | Change in fibrinolysis as indicated by PAI-1 level was calculated by taking the difference of measurements at baseline and 5 months. | 5 months | |
Secondary | Change in Von Williebrand Factor (vWF) | Change in vWF was calculated by taking the difference of measurements at baseline and 5 months. | 5 months | |
Secondary | Change in Protein S | Change in protein S was calculated by taking the difference of measurements at baseline and 5 months. | 5 months | |
Secondary | Change in Factor VIII | Change in factor VIII was calculated by taking the difference of measurements at baseline and 5 months. | 5 months | |
Secondary | Change in Fibrinogen | Change in fibrinogen was calculated by taking the difference of measurements at baseline and 5 months. | 5 months | |
Secondary | Change in Antithrombin | Change in antithrombin was calculated by taking the difference of measurements at baseline and 5 months. | 5 months | |
Secondary | Change in Protein C | Change in protein C was calculated by taking the difference of measurements at baseline and 5 months. | 5 months | |
Secondary | Change in Adiponectin | Change in adipontin was calculated by taking the difference of measurements at baseline and 5 months. | 5 months | |
Secondary | Patatin Like Phospholipase-3 (PNPLA3) rs738409 Polymorphism | Patatin like phospholipase-3 (PNPLA3) rs738409 polymorphism genotyping subjects (GG, GC and CC genotypes) | 5 months | |
Secondary | Change in PAI-1 Stratified by Fibrosis Stage | Change is the difference between measurements at baseline and 5 months | 5 months | |
Secondary | Change in % Hepatic Fat | Change in % hepatic fat was calculated by taking the difference of measurements at baseline and 5 months. | 5 months | |
Secondary | Health Related Quality of Life (HRQOL) Change | Data was collected at baseline and at 5 months to assess changes in domains of health.
PROMIS-29 Profile v2.1 (Physical function & pain interference) PROMIS Bank v2.0 - Instrumental Support (Social Support) Scores are reported as standardized T-score metrics derived from population means, with a mean of 50 and standard deviation of 10. The minimum is 0 and the maximum is 90. A higher score for fatigue, pain intensity, pain interference, sleep disturbance, anxiety and depression means a worse outcome. A higher score for physical function and social roles means a better outcome. |
5 months (20 weeks) |
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