The Liver Health Study for Patients With NAFLD

Obesity Clinical Trial

Official title:

Nutrient Overload, Insulin Resistance, and Hepatic Mitochondrial Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03151798
• Other study ID #: 2008258
• Status: Completed
• Phase: N/A
• Start date: August 9, 2017
• Est. completion date: April 29, 2023

Study information

• Verified date: July 2023
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 336
• Est. completion date: April 29, 2023
• Est. primary completion date: March 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver
• Nonalcoholic Steatohepatitis
• Obesity

Intervention

Behavioral:
• Phase II: Lifestyle treatment
Subjects will undergo energy restriction and exercise training over a 9 month period.
• 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

Locations

Country	Name	City	State
United States	University of Missouri	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver mitochondrial gene expression	Liver tissue will be tested in vitro to determine the abundance of transcript indicative of fat oxidation.	1 day
Secondary	Liver mitochondrial fat oxidation	Liver tissue will be tested in vitro to determine its capacity to burn fat	1 day
Secondary	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