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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 |
| |
| Oltipraz | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | 30mig/bid or 60mg/bid P.O |
| |
| Oltipraz |
| Measure | Description | Time Frame |
|---|---|---|
| MRS | To evaluate the efficacy of the Oltipraz on change in quantity of liver fat concentration assessed by MRS from baseline to 24 weeks in patients with non-alcoholic fatty liver disease | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| change in ALT, AST and total bilirubin | 24 weeks | |
| change in Cholesterol, Triglyceride | 24 weeks | |
| change in HOMA-IR |
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Inclusion Criteria:
Exclusion Criteria:
inflammatory bowel disease, autoimmune thrombocytopenic purpura, system lupus erythematosus, autoimmune hemolytic anemia, severe psoriasis, rheumatic arthritis and etc
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| Name | Affiliation | Role |
|---|---|---|
| YoonJun Kim, MD.PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University Ilsan Paik Hospital | Dahwa-dong, Ilsanseo-gu | Goyang-si, Gyeonggi-do | 411-706 | South Korea | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20664537 | Background | Kim SG, Kim YM, Choi YH, Lee MG, Choi JY, Han JY, Cho SH, Jang JW, Um SH, Chon CY, Lee DH, Jang JJ, Yu ES, Lee YS. Pharmacokinetics of oltipraz and its major metabolite (RM) in patients with liver fibrosis or cirrhosis: relationship with suppression of circulating TGF-beta1. Clin Pharmacol Ther. 2010 Sep;88(3):360-8. doi: 10.1038/clpt.2010.89. Epub 2010 Jul 21. | |
| 28225186 |
| Label | URL |
|---|---|
| Oltipraz | View source |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C026209 | oltipraz |
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| Drug |
30mig/bid or 60mg/bid P.O |
|
| 24 weeks |
| change in BMI | 24 weeks |
| changes in NAS | Subjects with liver biopsy: | 24 weeks |
| NHUS Ilsan Hospital |
| Ilsan-ro Ilsan-donggu |
| Goyang-si |
| 410-719 |
| 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 |
| Kim W, Kim BG, Lee JS, Lee CK, Yeon JE, Chang MS, Kim JH, Kim H, Yi S, Lee J, Cho JY, Kim SG, Lee JH, Kim YJ. Randomised clinical trial: the efficacy and safety of oltipraz, a liver X receptor alpha-inhibitory dithiolethione in patients with non-alcoholic fatty liver disease. Aliment Pharmacol Ther. 2017 Apr;45(8):1073-1083. doi: 10.1111/apt.13981. Epub 2017 Feb 22. |