Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
336 participants
INTERVENTIONAL
2017-08-09
2023-04-29
Brief Summary
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Detailed Description
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Inpatient comprehensive metabolic tests are performed before and after the nine-months.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
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
OTHER
SINGLE
Study Groups
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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
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
Phase II: Lifestyle treatment
Subjects will undergo lifestyle modification to cause weight loss and improved fitness
Phase II: Lifestyle treatment
Subjects will undergo energy restriction and exercise training over a 9 month period.
Phase II: Control treatment
Subjects will be given dietary advice and a stretching program.
Phase II: Control treatment
Subjects will receive dietary advice and receive information on a stretching program.
Interventions
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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.
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
Eligibility Criteria
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Inclusion Criteria
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
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
22 Years
65 Years
ALL
No
Sponsors
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University of Missouri-Columbia
OTHER
Responsible Party
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Elizabeth Jane Parks
Professor, Nutrition and Exercise Physiology
Principal Investigators
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Elizabeth Parks, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Missouri-Columbia
Jamal Ibdah, MD
Role: PRINCIPAL_INVESTIGATOR
University of Missouri-Columbia
Scott Rector, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Missouri-Columbia
Locations
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University of Missouri
Columbia, Missouri, United States
Countries
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References
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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.
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.
Other Identifiers
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2008258
Identifier Type: -
Identifier Source: org_study_id