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The Liver Health Study for Patients With NAFLD

Primary Purpose

Nonalcoholic Fatty Liver, Nonalcoholic Steatohepatitis, Obesity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Phase II: Lifestyle treatment

Phase II: Control treatment

Phase I: Observational studies

About this trial

This is an interventional other trial for Nonalcoholic Fatty Liver focused on measuring Nonalcoholic fatty liver, Exercise, Weight loss diet

Eligibility Criteria

22 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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
22-65 years of age
Sedentary, < 60 minutes per week of structured physical activity
Alcohol intake< 20 g/d

Exclusion Criteria:

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

Sites / Locations

University of Missouri

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Phase I: Observational studies

Phase II: Lifestyle treatment

Phase II: Control treatment

Arm Description

Patients are eligible who are undergoing either bariatric surgery or a liver biopsy for the diagnosis of nonalcoholic fatty liver disease

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

Subjects will be given dietary advice and a stretching program.

Outcomes

Primary Outcome Measures

Liver mitochondrial gene expression

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

Secondary Outcome Measures

Liver mitochondrial fat oxidation

Liver tissue will be tested in vitro to determine its capacity to burn fat

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.

Full Information

NCT ID

NCT03151798

First Posted

May 10, 2017

Last Updated

July 31, 2023

Sponsor

University of Missouri-Columbia

1. Study Identification

Unique Protocol Identification Number

NCT03151798

Brief Title

The Liver Health Study for Patients With NAFLD

Official Title

Nutrient Overload, Insulin Resistance, and Hepatic Mitochondrial Dysfunction

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

August 9, 2017 (Actual)

Primary Completion Date

March 3, 2022 (Actual)

Study Completion Date

April 29, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Missouri-Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nonalcoholic Fatty Liver, Nonalcoholic Steatohepatitis, Obesity

Keywords

Nonalcoholic fatty liver, Exercise, Weight loss diet

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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

Outcomes Assessor

Allocation

Randomized

Enrollment

336 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Phase I: Observational studies

Arm Type

Experimental

Arm Description

Patients are eligible who are undergoing either bariatric surgery or a liver biopsy for the diagnosis of nonalcoholic fatty liver disease

Arm Title

Phase II: Lifestyle treatment

Arm Type

Experimental

Arm Description

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

Arm Title

Phase II: Control treatment

Arm Type

Placebo Comparator

Arm Description

Subjects will be given dietary advice and a stretching program.

Intervention Type

Behavioral

Intervention Name(s)

Phase II: Lifestyle treatment

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Phase II: Control treatment

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Phase I: Observational studies

Intervention Description

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

Primary Outcome Measure Information:

Title

Liver mitochondrial gene expression

Description

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

Time Frame

1 day

Secondary Outcome Measure Information:

Title

Liver mitochondrial fat oxidation

Description

Liver tissue will be tested in vitro to determine its capacity to burn fat

Time Frame

1 day

Title

Histology to determine the amount of fibrosis in the liver

Description

Liver samples will be tested to determine the severity of liver disease and whether diet and exercise reduce liver fibrosis.

Time Frame

1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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: 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 22-65 years of age Sedentary, < 60 minutes per week of structured physical activity Alcohol intake< 20 g/d Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elizabeth Parks, PhD

Organizational Affiliation

University of Missouri-Columbia

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jamal Ibdah, MD

Organizational Affiliation

University of Missouri-Columbia

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Scott Rector, PhD

Organizational Affiliation

University of Missouri-Columbia

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Missouri

City

Columbia

State/Province

Missouri

ZIP/Postal Code

65212

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

The Liver Health Study for Patients With NAFLD

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