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Increasing Cure Rate of Hepatitis C Therapy in Obese Hepatitis C Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00871845
Recruitment Status : Terminated (Protocol expired and not renewed)
First Posted : March 30, 2009
Results First Posted : November 5, 2018
Last Update Posted : November 5, 2018
Information provided by (Responsible Party):
Hossam Kandil, University of Pittsburgh

Brief Summary:
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 or disease Intervention/treatment Phase
Obesity Insulin Resistance Metabolic Syndrome Hepatitis C Behavioral: Dietary and Lifestyle modification educational sessions Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Both groups followed for same period of time
Masking: None (Open Label)
Masking Description: Participants were divided into arms based upon BMI. Weight loss instruction/management provided only to overweight arm.
Primary Purpose: Prevention
Official Title: Effects of Dietary and Behavioral Intervention and Orlistat for Management of Obesity and Metabolic Syndrome on Response to Hepatitis C Therapy
Study Start Date : September 2008
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: LEAN (non obese, naive)
Patients naive to hepatitis C therapy with body mass index (BMI) <25
OVERWEIGHT (obese, naive, control)
Patients naive to hepatitis C therapy with BMI ≥ 25, received Dietary and Lifestyle modification educational sessions (one-time 15 minute weight loss instruction and pamphlet and enrolled into weight management program with 5 weekly one-hour nutrition and physical exercise education sessions after initial evaluation followed by monthly follow up.)
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:
  • weight management classes
  • weight reduction counseling

Primary Outcome Measures :
  1. Percentage of Participants With HCV RNA (Early Virological Response) [ Time Frame: Week 12 ]
    Early virological response (EVR) defined as a greater than 2-log10 decline in serum HCV RNA from the pretreatment baseline or an undetectable serum HCV RNA at treatment week 12

  2. Body Weight Loss [ Time Frame: Weight loss as of Week 12 ]
    Mean weight change from week 0 to week 12

  3. Percentage of Participants With Early Virological Response (EVR) and Significant Weight Loss [ Time Frame: Week 12 ]
    EVR compared between overweight subjects who achieved significant weight loss (>=3%) and those who did not

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00871845

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United States, Pennsylvania
Center for Liver Diseases, UPMC.
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Hossam Kandil
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Principal Investigator: Hossam M Kandil, MD, PhD assistant professor of medicine
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Responsible Party: Hossam Kandil, Principal Investigator, University of Pittsburgh Identifier: NCT00871845    
Other Study ID Numbers: PRO07090035
First Posted: March 30, 2009    Key Record Dates
Results First Posted: November 5, 2018
Last Update Posted: November 5, 2018
Last Verified: March 2018
Keywords provided by Hossam Kandil, University of Pittsburgh:
hepatitis C
insulin resistance
metabolic syndrome
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Metabolic Syndrome
Insulin Resistance
Pathologic Processes
Nutrition Disorders
Body Weight
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Glucose Metabolism Disorders
Metabolic Diseases