Effects of Dietary and Behavioral Intervention and Orlistat for Management of Obesity and Metabolic Syndrome on Response to Hepatitis C Therapy

This study is designed to be an interventional, prospective, randomized, double-blinded case-control clinical trial. Procedures will be done in the Center for Liver Diseases, 9'Th floor of Kaufmann medical building, UPMC, USA. This study will also be carried out in National Liver Institute, Egypt.

For treatment-naïve patients, we are targeting 32 subjects for each group; however, we are going to include 37 in each group to allow for estimated drop-outs rate of 15%. Subjects will be randomly assigned to 4 groups as follows: Group 1 includes non-obese controls (BMI < 25). They will receive one session of dietary and behavioral education. Groups 2, 3 and 4 include obese subjects (BMI ≥ 30). Group 2 includes obese controls who will receive one session of dietary and behavioral education. Groups 3 and 4 will receive up to 6 weekly sessions followed by 12 monthly sessions of dietary and behavioral education. Orlistat and placebo will be prescribed for Groups 3 and 4 respectively.

For non-responders and releasers to previous anti-hepatitis C therapy who have BMI ≥ 25 (overweight or obese), subjects will be randomized to groups 5 and 6 and will receive same treatment as groups 3 and 4, respectively. Their results will be compared to the historic controls results.

Screening procedures:

Verifying the eligibility of patients for participation in the study will be done through reviewing data in medical history, physical examination and investigations included in the patients' medical records. Acquired immuno-deficiency syndrome (AIDS) status of the participating subject will be determined by reviewing HIV ELISA screening test, reported in the subject's medical records as well. Measurements of weight and height (for BMI calculation) will be taken and recorded during the initial clinic visit at the center for liver diseases for all patients who agree to participate and fulfill the inclusion and exclusion criteria. Weight measure will be taken while patient is in light underwear and without shoes, while standing with his arms lying alongside the body, and in apnea fixed at midexpiratory phase while height measure will be taken by a wall-mounted stadiometer and recorded to the nearest cm.