The Liver Health Study for Patients with NAFLD

NCT03151798 | Completed DMC

• 1 other identifier: 2008258
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 1

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.

Conditions

Nonalcoholic Fatty Liver; Nonalcoholic Steatohepatitis; Obesity

Keywords

Nonalcoholic fatty liver; Exercise; Weight loss diet

Outcome Measures

Primary Outcomes (1)

• Liver mitochondrial gene expression

  Liver tissue will be tested in vitro to determine the abundance of transcript indicative of fat oxidation.

  1 day

Secondary Outcomes (2)

• Liver mitochondrial fat oxidation

  1 day

• Histology to determine the amount of fibrosis in the liver

  1 day

Study Arms (3)

Phase I: Observational studies

EXPERIMENTAL

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

Phase II: Lifestyle treatment

EXPERIMENTAL

Subjects will undergo lifestyle modification to cause weight loss and improved fitness

Behavioral: Phase II: Lifestyle treatment

Phase II: Control treatment

PLACEBO COMPARATOR

Subjects will be given dietary advice and a stretching program.

Behavioral: Phase II: Control treatment

Interventions

Phase II: Lifestyle treatment BEHAVIORAL

Subjects will undergo energy restriction and exercise training over a 9 month period.

Phase II: Lifestyle treatment

Phase II: Control treatment BEHAVIORAL

Subjects will receive dietary advice and receive information on a stretching program.

Phase II: Control treatment

Phase I: Observational studies OTHER

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

Phase I: Observational studies

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women (pre and post-menopausal)
• Overweight/obese with BMI ≥ 25.9 or \< 50.0 kg/m2
• 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
• years of age
• Sedentary, \< 60 minutes per week of structured physical activity
• Alcohol intake\< 20 g/d

You may not qualify if:

• Having undergone bariatric surgery.
• Acute disease or advanced cardiac or renal disease, anticoagulation therapy, or any severe co-morbid condition limiting life expectancy \< 1 years
• 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
• Use of steroids or other drugs that cause NAFLD
• Pregnant or trying to become pregnant
• Inability to exercise on a bike or treadmill

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

Related Publications (2)

• Syed-Abdul MM, Moore MP, Wheeler A, Ganga RR, Diaz-Arias A, Rector RS, Ibdah JA, Parks EJ. Improvements in nonalcoholic fatty liver disease (NAFLD) after metabolic surgery is linked to an increased hepatic fatty acid oxidation-a case report. AME Surg J. 2021 Jun 30;1:4. doi: 10.21037/asj-20-5.

  PMID: 40255245 DERIVED

• Mucinski JM, Salvador AF, Moore MP, Fordham TM, Anderson JM, Shryack G, Cunningham RP, Lastra G, Gaballah AH, Diaz-Arias A, Ibdah JA, Rector RS, Parks EJ. Histological improvements following energy restriction and exercise: The role of insulin resistance in resolution of MASH. J Hepatol. 2024 Nov;81(5):781-793. doi: 10.1016/j.jhep.2024.06.017. Epub 2024 Jun 22.

  PMID: 38914313 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Nutrition and Exercise Physiology

Model Details: 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

Study Record Dates

• First Submitted: May 10, 2017
• First Posted: May 12, 2017
• Study Start: August 9, 2017
• Primary Completion: March 3, 2022
• Study Completion: April 29, 2023
• Last Updated: December 19, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)