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

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ClinicalTrials.gov 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
Sponsor:
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

  Show Detailed Description

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


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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT00871845


Locations
United States, Pennsylvania
Center for Liver Diseases, UPMC.
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Hossam Kandil
Investigators
Principal Investigator: Hossam M Kandil, MD, PhD assistant professor of medicine

Responsible Party: Hossam Kandil, Principal Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00871845     History of Changes
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:
obesity
hepatitis C
insulin resistance
metabolic syndrome

Additional relevant MeSH terms:
Syndrome
Obesity
Hepatitis
Hepatitis A
Hepatitis C
Metabolic Syndrome X
Insulin Resistance
Disease
Pathologic Processes
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
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