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Insulin resistance is known to adversely effect viral response to treatment in hepatitis C patients
We are aiming to study the effect of an insulin sensitizer, metformin, in viral response of hepatitis C to treatment with pegylated interferon and ribavirin in a double blind randomized controlled trial
Subjects with hepatitis C will be randomized to receive standard treatment with or without metformin. The results will be compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | standard treatment with pegylated interferon and ribavirin + placebo |
|
| Metformin | Experimental | standard treatment with pegylated interferon and ribavirin + metformin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | 500 mg oral three times a day for 6 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained viral response, defined as undetectable virus RNA 6 months after end of treatment | 6 months after end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| adverse effects leading to discontinuation of treatment | anytime during the study | |
| Rapid viral response, defined as undetectable viral RNA one month after start of treatment | one month after start of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shahin Merat, MD | Digestive Disease Research Center, Medical Sciences / University of Tehran | Principal Investigator |
| Reza Malekzadeh, MD | Digestive Disease Research Center, Medical Sciences / University of Tehran | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shariati Hospital | Tehran | Tehran Province | 14114 | Iran |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D012263 |
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| pegylated interferon |
| Drug |
180 micrograms, or 1.5 micrograms/kg body weight weekly SQ injection for 6 or 12 months depending on genotype |
|
| Ribavirin | Drug | 800-1200 mg PO given in 2 divided doses for 6 to 12 months depending on weight and genotype |
|
| Early viral response, defined as undetectable viral RNA or 2 log drop in viral count three month after start of treatment | three months after start of treatment |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |