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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 : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Elizabeth Parks, University of Missouri-Columbia

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.

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

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  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
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)
Primary Purpose: Other
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


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Liver mitochondrial fat oxidation [ Time Frame: 1 day ]
    Liver tissue will be tested in vitro to determine its capacity to burn fat

  2. 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.



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Ages Eligible for Study:   22 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Elizabeth Parks, PhD 573-882-5864 parksej@missouri.edu
Contact: Scott Rector, PhD 573-814-6000 ext 53779 RectorS@health.missopuri.edu

Locations
United States, Missouri
University of Missouri Recruiting
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
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

Responsible Party: Elizabeth Parks, Professor, Nutrition and Exercise Physiology, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT03151798     History of Changes
Other Study ID Numbers: HS IRB #2008258
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Elizabeth Parks, University of Missouri-Columbia:
Nonalcoholic fatty liver
Exercise
Weight loss diet

Additional relevant MeSH terms:
Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases