The Liver Health Study for Patients With NAFLD

U

University of Missouri (MU)

Status

Completed

Conditions

Nonalcoholic Fatty Liver
Obesity
Nonalcoholic Steatohepatitis

Treatments

Other: Phase I: Observational studies
Behavioral: Phase II: Lifestyle treatment
Behavioral: Phase II: Control treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT03151798
2008258

Details and patient eligibility

About

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

Full 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.

Enrollment

336 patients

Sex

All

Ages

22 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

336 participants in 3 patient groups, including a placebo group

Phase I: Observational studies
Experimental group
Description:
Patients are eligible who are undergoing either bariatric surgery or a liver biopsy for the diagnosis of nonalcoholic fatty liver disease
Treatment:
Other: Phase I: Observational studies
Phase II: Lifestyle treatment
Experimental group
Description:
Subjects will undergo lifestyle modification to cause weight loss and improved fitness
Treatment:
Behavioral: Phase II: Lifestyle treatment
Phase II: Control treatment
Placebo Comparator group
Description:
Subjects will be given dietary advice and a stretching program.
Treatment:
Behavioral: Phase II: Control treatment

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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