NCT03151798

The Liver Health Study for Patients with NAFLD

Nutrient Overload, Insulin Resistance, and Hepatic Mitochondrial Dysfunction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 336 (actual)
• Sponsor: University of Missouri-Columbia · Academic / Other
• Sex: All
• Age: 22 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nonalcoholic Fatty Liver
• Nonalcoholic Steatohepatitis
• Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Phase II: Lifestyle treatment	Subjects will undergo energy restriction and exercise training over a 9 month period.
BEHAVIORAL	Phase II: Control treatment	Subjects will receive dietary advice and receive information on a stretching program.
OTHER	Phase 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

Timeline

• Start date: 2017-08-09
• Primary completion: 2022-03-03
• Completion: 2023-04-29
• First posted: 2017-05-12
• Last updated: 2024-12-19

Locations

1 site across 1 country: United States