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To evaluate the effect of treatment of insulin resistance in the response of chronic hepatitis C treatment, mesure as HCV-RNA negative at week 72.
4.3.2 Objetivos secundarios To evaluate the efficacy and safety of treatment with metformine to erradicate the insulin resistance of patients with chornic hepatitis C genotype 1 measure as HOMA-IR < 2.
Differents studies show that infection by virus hepatitis C have a relevant rol in the development of insulin resistance. The insulin resistence is associated with a progression of fibrosis and the development of steatosis. The insulin resistence is frecuently associated with very difficult to cure patients as cirrhotics, afro-american patients, overweight patients and co-infected HCV-HIV patients. Recently is repported that sustained virological (SVR) response in genotype 1 patients is different according the insulin resistance. The SVR was 60% in patients without insulin resistance versus 20% in patients with strong insulin resistance (HOMA > 4.
The present trial desire to analyze the effect that the treatment of insulin resistance produce in higher range of RVS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Placebo Comparator | Placebo of metformine 850-2550 mg/daily for 48 weeks |
|
| 1 | Experimental | Metformine 850-2550 mg/daily for 48 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformine | Drug | 850-2550 mg/daily for 48 weeks |
| |
| Placebo of metformine |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with HCV-RNA | Week 72 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients who has erradicated the insulin resistance | week 72 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manuel Romero-Gomez, Dr | Hospital Universitario de Valme. Sevilla | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain | ||
| Hospital del Mar |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Other |
850-2550 mg/daily for 48 weeks |
|
| Barcelona |
| Barcelona |
| 08003 |
| Spain |
| Hospital Parc Taulí | Sabadell | Barcelona | 08208 | Spain |
| Hospital General de Ciudad Real | Ciudad Real | Ciudad Real | 13005 | Spain |
| Hospital Reina Sofía | Córdoba | Córdoba | 14004 | Spain |
| Hospital Clínico Universitario San Cecilio | Granada | Granada | 18003 | Spain |
| Hospital Virgen de las Nieves | Granada | Granada | 18004 | Spain |
| Hospital de Donostia | Donostia / San Sebastian | Guipuzcoa | 20014 | Spain |
| Hospital de Leon | León | Leon | 24071 | Spain |
| Fundación Hospital de Alcorcón | Alcorcón | Madrid | 28922 | Spain |
| Hospital de la Princesa | Madrid | Madrid | 28006 | Spain |
| Hospital Gregorio Marañón | Madrid | Madrid | 28007 | Spain |
| Hospital Carlos III | Madrid | Madrid | 28029 | Spain |
| Hospital Puerta de Hierro | Madrid | Madrid | 28035 | Spain |
| Hospital La Paz | Madrid | Madrid | 28046 | Spain |
| Hospital Universitario Virgen de la Victoria | Málaga | Málaga | 29010 | Spain |
| Hospital Virgen Macarena | Seville | Sevilla | 41009 | Spain |
| Hospital Universitario de Valme | Seville | Sevilla | 41014 | Spain |
| Hospital General Universitario | Valencia | Valencia | 46014 | Spain |
| D006525 |
| Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |