The Liver Health Study for Patients With NAFLD
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|ClinicalTrials.gov Identifier: NCT03151798|
Recruitment Status : Recruiting
First Posted : May 12, 2017
Last Update Posted : May 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Nonalcoholic Fatty Liver Nonalcoholic Steatohepatitis Obesity||Behavioral: Phase II: Lifestyle treatment Behavioral: Phase II: Control treatment Other: Phase I: Observational studies||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|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
|Masking:||None (Open Label)|
|Official Title:||Nutrient Overload, Insulin Resistance, and Hepatic Mitochondrial Dysfunction|
|Actual Study Start Date :||April 26, 2017|
|Estimated Primary Completion Date :||May 31, 2022|
|Estimated Study Completion Date :||May 31, 2029|
Experimental: Phase I: Observational studies
Patients are eligible who are undergoing either bariatric surgery or a liver biopsy for the diagnosis of nonalcoholic fatty liver disease
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
Experimental: Phase II: Lifestyle treatment
Subjects will undergo lifestyle modification to cause weight loss and improved fitness
Behavioral: Phase II: Lifestyle treatment
Subjects will undergo energy restriction and exercise training over a 9 month period.
Placebo Comparator: Phase II: Control treatment
Subjects will be given dietary advice and a stretching program.
Behavioral: Phase II: Control treatment
Subjects will receive dietary advice and receive information on a stretching program.
- Liver mitochondrial gene expression [ Time Frame: 1 day ]Liver tissue will be tested in vitro to determine the abundance of transcript indicative of fat oxidation.
- Liver mitochondrial fat oxidation [ Time Frame: 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 [ Time Frame: 1 day ]Liver samples will be tested to determine the severity of liver disease and whether diet and exercise reduce liver fibrosis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03151798
|Contact: Elizabeth Parks, PhDfirstname.lastname@example.org|
|Contact: Scott Rector, PhD||573-814-6000 ext 53779||RectorS@health.missopuri.edu|
|United States, Missouri|
|University of Missouri||Recruiting|
|Columbia, Missouri, United States, 65212|
|Principal Investigator:||Elizabeth Parks, PhD||University of Missouri-Columbia|
|Principal Investigator:||Jamal Ibdah, MD||University of Missouri-Columbia|
|Principal Investigator:||Scott Rector, PhD||University of Missouri-Columbia|