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The study will investigate whether the level of fat stored in the liver is related to the liver's ability to burn fat.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Phase II: Lifestyle treatment | Experimental | Subjects will undergo lifestyle modification to cause weight loss and improved fitness |
|
| Phase II: Control treatment | Placebo Comparator | Subjects will be given dietary advice and a stretching program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phase II: Lifestyle treatment | Behavioral | Subjects will undergo energy restriction and exercise training over a 9 month period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Liver mitochondrial gene expression | Liver tissue will be tested in vitro to determine the abundance of transcript indicative of fat oxidation. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Liver mitochondrial fat oxidation | Liver tissue will be tested in vitro to determine its capacity to burn fat | 1 day |
| 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. |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri | Columbia | Missouri | 65212 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40255245 | Derived | 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. | |
| 38914313 | Derived |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 17, 2026 | |
| Reset | Mar 12, 2026 | |
| Release | Mar 17, 2026 | |
| Reset | Apr 6, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 17, 2026 | Mar 12, 2026 | |||
| Mar 17, 2026 |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D009765 | Obesity |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D050177 | Overweight |
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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
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| Phase II: Control treatment | Behavioral | Subjects will receive dietary advice and receive information on a stretching program. |
|
| 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 |
|
| 1 day |
| 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. |
| Apr 6, 2026 |
| D044343 |
| Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |