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Dithiolethiones, a novel class of adenosine monophosphate-activated protein kinase (AMPK) activators, prevent insulin resistance through AMPK-dependent p70 ribosomal S6 kinase-1 (S6K1) inhibition. And it is well known that the modulation of S6K1 by oltipraz inhibited the development of insulin resistance and hyperglycemia through the AMPK-S6K1 pathway.Also some research reported that LXRg (a member of the nuclear hormone receptor)-mediated increases in SREBP-1c (the sterol regulatory element-binding protein-1c gene) promote the expression of lipogenic genes and enhance fatty acid synthesis and oltipraz inhibits LXRg and SREBP-c. Therefore, Oltipraz inhibits fatty acid synthesis through AMPK-S6K1 pathway and LXRg-SREBP-1c pathway in liver.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo Comparator / Tid (total 0mg) |
|
| Oltipraz 1 | Experimental | Total 90mg, by mouth, tid |
|
| Oltipraz 2 | Experimental | Total 120mg, by mouth, tid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oltipraz 1 (90mg) | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| MRS(magnetic resonance spectroscopy) | To evaluate the efficacy of the Oltipraz on change in quantity of liver fat (% change) assessed by MRS from baseline to 24 weeks in patients. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| change in liver fat concentration | 24 weeks | |
| change in BMI | 8, 16, 24 weeks | |
| change in NAFLD Fibrosis score (NFS) |
| Measure | Description | Time Frame |
|---|---|---|
| change in Adipokine, CK-18 | 8, 16, 24 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NHUS Ilsan Hospital | Ilsan-ro Ilsan-donggu | Goyang-si | 410-719 | South Korea | ||
| Inje University Ilsan Paik Hospital |
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|
| Oltipraz 2 (120mg) | Drug |
|
| 24 weeks |
| change in ALT, AST, γ-GT | 8, 16, 24 weeks |
| change in Cholesterol (total, LDL, HDL, VLDL), Triglyceride (TG) | 8, 16, 24 weeks |
| change in HOMA-IR | 8, 16, 24 weeks |
| change in waist circumference | 24 weeks |
| Dahwa-dong, Ilsanseo-gu, Goyang-si |
| Gyeonggi-do |
| 411-706 |
| South Korea |
| Seoul National University Hospital | Daehak-ro Jongno-gu | Seoul | 110-744 | South Korea |
| Korea University Guro hospital | Gurodong-ro | Seoul | 152-703 | South Korea |
| Boramae Hospital | Sindaebang-dong Dongjak-gu | Seoul | 156-707 | South Korea |