The Liver Health Study for Patients with NAFLD

Not Applicable

Completed

• Conditions: Nonalcoholic Steatohepatitis; Obesity; Nonalcoholic Fatty Liver

• Registration Number: NCT03151798
• Lead Sponsor: University of Missouri-Columbia

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.

Study Timeline

• Study First Submitted: 2017-05-10
• Study First Submitted QC: 2017-05-10
• Study First Posted: 2017-05-12
• Study Start: 2017-08-09
• Primary Completion: 2022-03-03
• Study Completion: 2023-04-29
• Status Verified: 2023-07
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 336

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.
Liver mitochondrial fat oxidation	1 day	Liver tissue will be tested in vitro to determine its capacity to burn fat

Trial Locations

Locations (1)

University of Missouri; 🇺🇸 Columbia, Missouri, United States