The Liver Health Study for Patients with NAFLD

Nutrient Overload, Insulin Resistance, and Hepatic Mitochondrial Dysfunction

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

Study Overview

• Status: Completed
• Conditions: Obesity; Nonalcoholic Steatohepatitis; Nonalcoholic Fatty Liver
• Intervention / Treatment: Other: Phase I: Observational studies; Behavioral: Phase II: Lifestyle treatment; Behavioral: Phase II: Control treatment

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 Type: Interventional
• Enrollment (Actual): 336
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2017
• Primary Completion (Actual): March 3, 2022
• Study Completion (Actual): April 29, 2023

Study Registration Dates

• First Submitted: May 10, 2017
• First Submitted That Met QC Criteria: May 10, 2017
• First Posted (Actual): May 12, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2024
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Exercise; Nonalcoholic fatty liver; Weight loss diet
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 2008258

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No