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N/A N=28 Randomized Treatment

NASH Fitness Intervention in Thrombosis Trial (NASHFit)

Liver Diseases · Blood Disorder · Digestive System Disease

Enrolled (actual)
28
Serious AEs
3.6%
Results posted
Feb 2023
Primary outcome: Primary: PAI-1 Level — 151.4; 176.2 ng/mL

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Aerobic Exercise (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Milton S. Hershey Medical Center
Primary completion
Mar 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
PAI-1 Level
151.4; 176.2
SECONDARY
Change in Von Williebrand Factor (vWF)
140.1; 128.4
SECONDARY
Change in Protein S
106.3; 101.5
SECONDARY
Change in Factor VIII
210.0; 188.6
SECONDARY
Change in Fibrinogen
352.4; 377.2
SECONDARY
Change in Antithrombin
95.6; 102.2
SECONDARY
Change in Protein C
169.0; 152.6
SECONDARY
Change in Adiponectin
3482.3; 1065.1
SECONDARY
Patatin Like Phospholipase-3 (PNPLA3) rs738409 Polymorphism
3; 8; 5; 5; 2; 5
SECONDARY
Change in PAI-1 Stratified by Fibrosis Stage
176.7; 241.4; 131.7; 122.7; 196.1; 127.8
SECONDARY
Change in % Hepatic Fat
22.5; 20.4
SECONDARY
Health Related Quality of Life (HRQOL) Change
-2.5; 1.5; 4.3; -3.4; -0.7; 5.0

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.

Eligibility Criteria

Inclusion Criteria Adults age >=18 or 90 minutes/week of at least moderate intensity exercise over the previous three months Pregnancy BMI 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 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 ¼ mile. Physical Activity Readiness Questionnaire (PAR-Q) score >=1 at the discretion of the study PI
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03518294). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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