Increasing Cure Rate of Hepatitis C Therapy in Obese Hepatitis C Patients
Recruitment status was Recruiting
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Purpose
The purpose of this study is to determine whether obese people do not respond to hepatitis C treatment as well as lean people. This research studies whether obese people will show higher sustained virologic response rate if they lose weight by Orlistat use and dietary and lifestyle modification.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity Insulin Resistance Metabolic Syndrome Hepatitis C |
Drug: Orlistat Behavioral: Dietary and Lifestyle modification educational sessions |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Effects of Dietary and Behavioral Intervention and Orlistat for Management of Obesity and Metabolic Syndrome on Response to Hepatitis C Therapy |
- HCV RNA [ Time Frame: before starting Pegylated Interferon, and every 12 wks after wards for 6 times, ] [ Designated as safety issue: No ]
- Body weight [ Time Frame: before starting Pegylated Interferon, and every 12 wks after wards for 6 times ] [ Designated as safety issue: No ]
- waist circumference [ Time Frame: before starting Pegylated Interferon, and every 12 wks after wards for 6 times ] [ Designated as safety issue: No ]
- skin fold thickness [ Time Frame: before starting Pegylated Interferon, and every 12 wks after wards for 6 times ] [ Designated as safety issue: No ]
- HOMA, IR [ Time Frame: before starting Pegylated Interferon, and every 12 wks after wards for 6 times ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 222 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: 1) non obese, naive
Patients naive to hepatitis C therapy with body mass index (BMI) <25
|
|
|
No Intervention: 2) obese, naive, control
Patients naive to hepatitis C therapy with BMI ≥ 30
|
|
|
Active Comparator: 3) obese, naive, orlistat
Patients naive to hepatitis C therapy with BMI ≥ 30 as an interventional group, patients will receive up to 6 sessions of dietary and physical education after which they will start receiving their standard hepatitis C treatment. they will be encouraged to attend up to 12 monthly meetings (along side the monthly visits for their standard viral hepatitis therapy) at the health education room of center for liver diseases, to check dietary diaries. The dietary and physical education (given through up to 6 weekly sessions and subsequently up to 12 monthly follow-up meetings) will be presented. Orlistat (60 mg capsules, three times daily, before meals) will be prescribed for a time frame starting 3 to 6 weeks prior to and during the 48 weeks of the standard anti-viral therapy. |
Drug: Orlistat
Orlistat 60 mg capsules, three times daily, before meals) will be prescribed for a time frame starting 3 to 6 weeks prior to and during the 48 weeks of the standard anti-HCV therapy.
Other Names:
|
|
Placebo Comparator: 4) obese, naive, Placebo
Patients naive to hepatitis C therapy with BMI ≥ 30 as an interventional group, patients will receive up to 6 sessions of dietary and physical education after which they will start receiving their standard hepatitis C treatment. they will be encouraged to attend up to 12 monthly meetings (along side the monthly visits for their standard viral hepatitis therapy) at the health education room of center for liver diseases, to check dietary diaries. The dietary and physical education (given through up to 6 weekly sessions and subsequently up to 12 monthly follow-up meetings) will be presented. Placebo will be prescribed for a time frame starting 3 to 6 weeks prior to and during the 48 weeks of the standard anti-viral therapy. |
Behavioral: Dietary and Lifestyle modification educational sessions
6 sessions of dietary and physical education after which they will start receiving their standard hepatitis C treatment. they will be encouraged to attend up to 12 monthly meetings (along side the monthly visits for their standard viral hepatitis therapy.
Other Names:
|
|
Active Comparator: 5) obese, non-naive, orlistat
Patients non responder or relapser after previous course of Hepatitis C therapy, with BMI ≥ 25. Patients will receive up to 6 sessions of dietary and physical education after which they will start receiving their standard hepatitis C treatment. they will be encouraged to attend up to 12 monthly meetings (along side the monthly visits for their standard viral hepatitis therapy. The dietary and physical education. Orlistat 60 mg capsules, three times daily, before meals) will be prescribed for a time frame starting 3 to 6 weeks prior to and during the 48 weeks of the standard anti-viral therapy. |
Drug: Orlistat
Orlistat 60 mg capsules, three times daily, before meals) will be prescribed for a time frame starting 3 to 6 weeks prior to and during the 48 weeks of the standard anti-HCV therapy.
Other Names:
|
|
Placebo Comparator: 6) obese, non-naive, Placebo
Patients naive to hepatitis C therapy with BMI ≥ 30 as an interventional group, patients will receive up to 6 sessions of dietary and physical education after which they will start receiving their standard hepatitis C treatment. they will be encouraged to attend up to 12 monthly meetings (along side the monthly visits for their standard viral hepatitis therapy) at the health education room of center for liver diseases, to check dietary diaries. The dietary and physical education (given through up to 6 weekly sessions and subsequently up to 12 monthly follow-up meetings) will be presented. Placebo will be prescribed for a time frame starting 3 to 6 weeks prior to and during the 48 weeks of the standard anti-viral therapy. |
Behavioral: Dietary and Lifestyle modification educational sessions
6 sessions of dietary and physical education after which they will start receiving their standard hepatitis C treatment. they will be encouraged to attend up to 12 monthly meetings (along side the monthly visits for their standard viral hepatitis therapy.
Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 18 years or older
- positive diagnosis of hepatitis C, by Polymerase Chain Reaction (PCR
- scheduled to start treatment of hepatitis C by peg interferon and ribavirin
- agreeing to give a written consent to participate in this study.
Exclusion Criteria:
- patients under 18 years of age
- refusal to give a consent to participate in the study
- history of recreational drug or alcohol use in the preceding 6 months
- pregnancy by hCG pregnancy testing which will be done prior to and monthly during the 12 month hepatitis C therapy and for 6 months following the end of treatment
- plan for pregnancy during the study period
- failure to adhere to contraceptive methods
- HIV disease
- evidence of cirrhosis or confirmed hepatocellular carcinoma (HCC), evidence of decompensated liver disease or presence of other liver diseases such as hepatitis B, hemochromatosis, autoimmune hepatitis and Wilson disease
- Patients will be removed from the study if they develop severe side effects to IFN (e.g marked depression, autoimmune reactions like thyroiditis, aplastic anemia..), severe side effects to ribavirin (e.g. marked hemolysis) or intolerance of Orlistat/placebo (e.g. allergic reaction, diarrhea, flatulence..) and withdrawal of the consent.
Contacts and Locations| Contact: Hossam M Kandil, assist Prof | 412-647-1170 | hmk2@pitt.edu |
| United States, Pennsylvania | |
| Center for Liver Diseases, UPMC. | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Hossam M Kandil, M.D, Ph.D 412-647-9268 hmk2@pitt.edu | |
| Principal Investigator: | Hossam M Kandil, MD, PhD | assistant professor of medicine |
More Information
No publications provided
| Responsible Party: | Hossam Kandil, University of Pittsburgh Medical Center / Center for Liver Diseases |
| ClinicalTrials.gov Identifier: | NCT00871845 History of Changes |
| Other Study ID Numbers: | PRO07090035 |
| Study First Received: | March 26, 2009 |
| Last Updated: | March 26, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Pittsburgh:
|
obesity hepatitis C insulin resistance metabolic syndrome |
Additional relevant MeSH terms:
|
Hepatitis C Hepatitis Hepatitis A Insulin Resistance Obesity Metabolic Syndrome X Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Hyperinsulinism |
Glucose Metabolism Disorders Metabolic Diseases Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Orlistat Anti-Obesity Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013