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

NCT00871845 | Terminated Results DMC

• 1 other identifier: PRO07090035
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Insulin Resistance; Metabolic Syndrome; Hepatitis C

Keywords

obesity; hepatitis C; insulin resistance; metabolic syndrome

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants With HCV RNA (Early Virological Response)

  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

  Week 12

• Body Weight Loss

  Mean weight change from week 0 to week 12

  Weight loss as of Week 12

• Percentage of Participants With Early Virological Response (EVR) and Significant Weight Loss

  EVR compared between overweight subjects who achieved significant weight loss (\>=3%) and those who did not

  Week 12

Study Arms (2)

LEAN (non obese, naive)

NO INTERVENTION

Patients naive to hepatitis C therapy with body mass index (BMI) \<25

OVERWEIGHT (obese, naive, control)

OTHER

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

Interventions

Dietary and Lifestyle modification educational sessions BEHAVIORAL

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.

Also known as: weight management classes, weight reduction counseling

OVERWEIGHT (obese, naive, control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hossam Kandil: lead

Study Sites (1)

Center for Liver Diseases, UPMC.

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Obesity; Insulin Resistance; Metabolic Syndrome; Hepatitis C

Interventions

Diet

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Limitations and Caveats

Study design adjusted due to subject availability \& financial constraints. The drug intervention was not done. Waist circum \& skin fold thickness not done due to patient refusal. HOMA/IR not done as not available/performed by primary providers.

Results Point of Contact

• Title: Hossam Kandil
• Organization: Allegheny Singer Research Institute

Hossam.KANDIL@ahn.org

Study Officials

• Hossam M Kandil, MD, PhD

  assistant professor of medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Participants were divided into arms based upon BMI. Weight loss instruction/management provided only to overweight arm.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Both groups followed for same period of time

Study Record Dates

• First Submitted: March 26, 2009
• First Posted: March 30, 2009
• Study Start: September 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: November 5, 2018
• Results First Posted: November 5, 2018

Record last verified: 2018-03

Locations

US (1)