The Liver Health Study for Patients With NAFLD

The study has two phases. In Phase I, liver samples from patients undergoing bariatric
surgery or a diagnostic liver biopsy will be tested for the ability to burn fatty acids. In
Phase II, patients with nonalcoholic fatty liver disease will participate in either a
nine-month lifestyle treatment program or undergo standard care. The goal is to determine how
weight loss and exercise improve liver health.

Inpatient comprehensive metabolic tests are performed before and after the nine-months.

For Phase I: Any patient scheduled to undergo bariatric surgery or a liver biopsy to
diagnose nonalcoholic fatty liver disease.

For Phase II: Only subjects who have had a diagnosis of nonalcoholic fatty liver disease
and completed Phase I (and no subjects who have undergone bariatric surgery)

Inclusion Criteria:

1. Men and women (pre and post-menopausal)

2. Overweight/obese with BMI ≥ 25.9 or < 50.0 kg/m2

3. Characteristics of the metabolic syndrome, pre-diabetes (fasting glucose 100-125 mg/dL
or 2h glucose 140-200 mg/dL) or diabetes type 2, or undergoing bariatric surgery

4. 22-65 years of age

5. Sedentary, < 60 minutes per week of structured physical activity

6. Alcohol intake< 20 g/d

Exclusion Criteria:

1. Having undergone bariatric surgery.

2. Acute disease or advanced cardiac or renal disease, anticoagulation therapy, or any
severe co-morbid condition limiting life expectancy < 1 years

3. Other causes of hepatitis including hepatitis B & C, autoimmune hepatitis,
hemochromatosis, celiac disease, Wilson's disease, alpha-1-antitrypsin deficiency,
medication-induced hepatitis, any clinical or biochemical evidence of decompensated
liver disease

4. Use of steroids or other drugs that cause NAFLD

5. Pregnant or trying to become pregnant

6. Inability to exercise on a bike or treadmill