NCT00546442

Treatment Insulin Resistence in HCV G-1 Patient

Effect of Treatment of Insulin Resistance in Patients With Chronic Hepatitis C Genotype 1 Treated With Peginterferon Alfa-2a in Combination With Ribavirin in Current Clinical Practice

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Valme University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	Metformine	850-2550 mg/daily for 48 weeks
OTHER	Placebo of metformine	850-2550 mg/daily for 48 weeks

Timeline

• Start date: 2006-05-01
• Completion: 2007-01-01
• First posted: 2007-10-19
• Last updated: 2007-10-19

Locations

19 sites across 1 country: Spain