Clinical trial NCT03151798: The Liver Health Study for Patients with NAFLD
Official title: Nutrient Overload, Insulin Resistance, and Hepatic Mitochondrial Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nonalcoholic Fatty Liver
Nonalcoholic Steatohepatitis
Obesity
Keywords: Nonalcoholic fatty liver
Exercise
Weight loss diet
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 336
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: In Phase I, liver samples derived from patients undergoing either bariatric surgery or a liver biopsy to diagnose nonalcoholic fatty liver disease, are tested one time in vitro. There is no treatment in Phase I.

In Phase II, only patients with nonalcoholic fatty liver disease (and not those who have had bariatric surgery) are eligible to go into a study in which they are randomly assigned to 1) a lifestyle treatment program or 2) a control group undergoing standard care. Allocation is 2:1 subjects in the treatment vs standard care groups.

Thus, the arms are:

Arm 1: Phase I studies with no treatment, only observational data generated in vitro from the liver samples Arm 2: Phase II lifestyle treatment Arm 3: Phase II control standard of care
Primary purpose: OTHER

Brief summary: The study will investigate whether the level of fat stored in the liver is related to the liver's ability to burn fat.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Liver mitochondrial gene expression
timeFrame: 1 day
Secondary outcomes:
measure: Liver mitochondrial fat oxidation
timeFrame: 1 day
measure: Histology to determine the amount of fibrosis in the liver
timeFrame: 1 day
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Elizabeth Parks, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Missouri-Columbia
name: Jamal Ibdah, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Missouri-Columbia
name: Scott Rector, PhD
role: PRINCIPAL_INVESTIGATOR
References: