Improving Fibrosis Outcomes With Metformin
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|ClinicalTrials.gov Identifier: NCT02306070|
Recruitment Status : Withdrawn (insufficient funding)
First Posted : December 3, 2014
Last Update Posted : April 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|HIV Infection Hepatitis C||Drug: Metformin Drug: No metformin treatment||Phase 2|
HCV antiviral therapy has evolved rapidly in recent years and access to these medications has improved. While SVR is associated with improved liver outcomes, the rate of liver fibrosis regression with SVR is variable and predictors of regression are not well established. In addition, achieving SVR in patients with cirrhosis does not necessarily prevent decompensation or eliminate the risk of HCC. A better understanding of the role insulin resistance and impaired glucose metabolism have on these outcomes in HCV patients who achieve SVR are needed.
Identifying and targeting potentially modifiable risk factors such as IR may be of significant importance in preventing progression of and promoting regression of liver fibrosis, reducing mortality and improving outcomes for HCV-HIV co-infected and HCV-mono-infected patients.
This proposed pilot study will be the first to evaluate the role of Metformin on liver fibrosis in HCV-HIV co-infected and HCV mono-infected patients with IR receiving DAA HCV treatment.
If Metformin is effective in reducing liver fibrosis in this patient population, this will represent a well-tolerated, easy to administer, inexpensive therapy that will protect against negative HCV outcomes. This study will also be an opportunity to evaluate the impact of insulin resistance and hyperglycemia have on viral clearance HCV-infected patients treated with interferon-free regimens. In addition, the study will further explore the relationship between HCV, insulin resistance and AFP levels.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Improving Treatment and Liver Fibrosis Outcomes With Metformin in HCV-HIV Co-infected and HCV Mono-infected Patients With Insulin Resistance.|
|Study Start Date :||January 2016|
|Actual Primary Completion Date :||September 30, 2017|
|Estimated Study Completion Date :||April 3, 2018|
Experimental: Metformin + lifestyle modification
Metformin + lifestyle modification pre, during and post HCV antiviral therapy
metformin treatment + standard of care dietary and exercise advice
Other Name: lifestyle modification
Placebo Comparator: No Metformin + Lifestyle modification
No metformin + lifestyle modification pre, during and post HCV antiviral therapy.
Drug: No metformin treatment
no metformin treatment + standard of care dietary and exercise advice
Other Name: lifestyle modification
- Change in FibroScan® score (kPa) from baseline to week 12 (start of HCV treatment), compared between treatment groups. [ Time Frame: 12 weeks ]liver elastography score (kPa)
- Virological response rates (SVR 12 weeks post HCV antiviral therapy) between treatment groups. [ Time Frame: 12 weeks ]HCV RNA level (IU/mL)
- Change in APRI measurements from baseline compared between treatment groups. [ Time Frame: 12, 24, 48weeks ]calculated APRI
- Change from baseline in glucose metabolism (HOMA-IR, fasting insulin, glucose levels) [ Time Frame: 4, 8, 12, 24, 36, 48 weeks ]fasting glucose and insulin
- Changes from baseline in lipid levels [ Time Frame: 12, 36, 48 weeks ]fasting total cholesterol, LDL-c, HDL-c, triglycerides
- Changes from baseline in anthropometric measures [ Time Frame: 4, 8, 12, 24, 36, 48 weeks ]waist circumference, body weight and BMI
- Changes from baseline in liver-related inflammatory markers [ Time Frame: 4, 8, 12, 24, 36 weeks ]IL-6, IL-8, TNF-alpha, TGF-beta, C-reactive protein
- Changes in AFP levels from baseline [ Time Frame: 12, 24, 36, 48 weeks ]AFP
- Participant acceptability to study medication dosing (in Arm 1 only) [ Time Frame: 8, 24, 48 weeks ]Participant acceptability will be evaluated in Arm 1 only using the Treatment Satisfaction Questionnaire for Medication (TSQM), Version 1.4
- Changes from baseline in diet [ Time Frame: 24, 48 weeks ]Changes in diet from baseline will be captured using the International Physical Activity Questionnaire short-form (IPAQ-sf)
- Changes from baseline in physical exercise parameters [ Time Frame: 24, 48 weeks ]Changes in physical activity from baseline will be captured using the International Physical Activity Questionnaire short-form (IPAQ-sf)
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): NCT02306070
|The Ottawa Hospital, General Campus|
|Ottawa, Ontario, Canada|
|Principal Investigator:||Curtis Cooper, MD||The Ottawa Hospital Division of Infectious Diseases|