Insulin Resistance Associated With Chronic Hepatitis C (CHC) and the Effect of Antiviral Therapy
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|ClinicalTrials.gov Identifier: NCT00188240|
Recruitment Status : Unknown
Verified September 2005 by University Health Network, Toronto.
Recruitment status was: Recruiting
First Posted : September 16, 2005
Last Update Posted : November 29, 2005
The literature suggests that there may be an association between hepatitis C and type 2 diabetes mellitus independent of the presence of cirrhosis, the likely mechanism for which is insulin resistance. The prevalence of insulin resistance in patients with hepatitis C is unknown. Furthermore, there are no studies that indicate an increased prevalence of insulin resistance in patients with hepatitis C compared to other etiologies of liver disease. The role that hepatitis C may have in the development of insulin resistance is unclear. The effect of antiviral therapy for hepatitis C virus on insulin resistance has not been addressed. The long-term consequence of insulin resistance is type 2 diabetes mellitus. There is significant morbidity and mortality from type 2 diabetes mellitus in the general population, and similar complications would be expected in patients with hepatitis C and insulin resistance particularly if they develop type 2 diabetes mellitus.
Our hypothesis: The prevalence of insulin resistance is increased in patients with chronic hepatitis C compared to chronic hepatitis B. Secondarily, insulin resistance when present in patients with chronic hepatitis C improves with successful antiviral therapy.
This study has two phases. The first phase of our study will be to estimate the prevalence of insulin resistance in individuals with chronic hepatitis C without cirrhosis compared to patients with chronic hepatitis B without cirrhosis. The second phase of the study will be restricted to those patients with hepatitis C found to be insulin resistant from phase 1, in the absence of known risk factors for insulin resistance (cirrhosis, diabetes). The effect on insulin resistance of anti-viral therapy to eradicate hepatitis C will be assessed.
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C Hepatitis B||Drug: Pegasys; Copegus.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Insulin Resistance Associated With Chronic Hepatitis C (CHC) and the Effect of Anti-Viral Therapy|
|Study Start Date :||August 2003|
- Phase I - To evaluate the prevalence of insulin resistance in patients with hepatitis C without cirrhosis and compare it to that observed in patients with hepatitis B also without cirrhosis.
- Phase II - Interventional phase - To evaluate the effect of anti-viral therapy on insulin resistance, determined by the OGTT method, in patients with hepatitis C found to have insulin resistance pre-treatment.
- - To evaluate the safety, efficacy and tolerability of Pegasys (peginterferon alfa-2a) given in combination with Copegus (ribavirin) given for 24 weeks or 48 weeks in treatment naïve patients with chronic hepatitis C (CHC).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00188240
|Contact: Tharini Ganeshram||416-603-5839|
|Liver Clinic, Toronto Western Hospital, UHN.||Recruiting|
|Toronto, Ontario, Canada, M5T 2S8|
|Contact: E.J.L. (Jenny) Heathcote, MD 416-603-5914|
|Principal Investigator: E.J.L (Jenny) Heathcote, M.D.|
|Principal Investigator:||E.J.L (Jenny) Heathcote, MD||UHN - Toronto Western Hospital, University of Toronto|