The Liver Health Study for Patients with NAFLD

Conditions

Nonalcoholic Fatty Liver, Nonalcoholic Steatohepatitis, Obesity

Keywords

Nonalcoholic fatty liver, Exercise, Weight loss diet

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.

Mucinski JM, Salvador AF, Moore MP, Fordham TM, Anderson JM, Shryack G, Cunningham RP, Lastra G, Gaballah AH, Diaz-Arias A, Ibdah JA, Rector RS, Parks EJ.

2024-06-2231 citations

10.1016/j.jhep.2024.06.017

S1061 Alkaline Phosphatase Is an Independent Predictor of Significant Liver Fibrosis in Obese Subjects with Nonalcoholic Fatty Liver Disease

Ahmad Ali, Gregory F. Petroski, Alberto A. Diaz‐Arias, Alhareth Al Juboori, Andrew A. Wheeler et al. (12 authors)

The American Journal of Gastroenterology2021-10-01

10.14309/01.ajg.0000777776.58994.9c

Improvements in nonalcoholic fatty liver disease (NAFLD) after metabolic surgery is linked to an increased hepatic fatty acid oxidation—a case report

Majid Mufaqam Syed‐Abdul, Mary P. Moore, Andrew A. Wheeler, Rama Ganga, Alberto A. Diaz‐Arias et al. (8 authors)

AME Surgical Journal2021-06-014 citations

10.21037/asj-20-5

Interventions

BEHAVIORALPhase II: Lifestyle treatment

Subjects will undergo energy restriction and exercise training over a 9 month period.

BEHAVIORALPhase II: Control treatment

Subjects will receive dietary advice and receive information on a stretching program.

OTHERPhase I: Observational studies

The liver samples from patients undergoing bariatric surgery or a diagnostic liver biopsy will undergo in vitro assays to determine the capacity of the tissue to burn fat

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

SINGLE (Outcomes Assessor)

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

Eligibility

Sex/Gender

ALL

Age

22 Years to 65 Years

Healthy volunteers

No

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
Liver mitochondrial gene expression	1 day	Liver tissue will be tested in vitro to determine the abundance of transcript indicative of fat oxidation.

Secondary

Measure	Time frame	Description
Liver mitochondrial fat oxidation	1 day	Liver tissue will be tested in vitro to determine its capacity to burn fat
Histology to determine the amount of fibrosis in the liver	1 day	Liver samples will be tested to determine the severity of liver disease and whether diet and exercise reduce liver fibrosis.

Countries

United States

Outcome results

None listed