Hypertriglyceridemia
Conditions
Keywords
hypertriglyceridemia, triglyceride, cholesterol, Maraviroc
Brief summary
The purpose of this study is to determine the effect of maraviroc therapy in obese insulin resistant subjects on: 1. Plasma triglyceride concentration 2. Plasma HDL-cholesterol and LDL-cholesterol concentrations 3. Plasma markers of cardiometabolic risk and inflammation
Detailed description
The purpose of this study is to determine, in obese insulin resistant subjects, the effect of maraviroc therapy, a selective antagonist of the human chemokine receptor CCR5, on: 1. Plasma triglyceride concentration 2. Plasma HDL-cholesterol and LDL-cholesterol concentrations 3. Plasma markers of cardiometabolic risk and inflammation
Interventions
DRUGMaraviroc
dosage will be a 300mg Maraviroc pill twice a day for 12 weeks
OTHERplacebo
subjects will be given placebo pills with instructions to take one pill twice a day for 12 weeks.
Sponsors
Pfizer
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* obese (body mass index (BMI) between 30 and 45.9) * increased plasma triglyceride concentrations (150-400 mg/dL)
Exclusion criteria
* active or previous infection with hepatitis B or C * history of alcohol abuse * current alcohol consumption (\>20g/day) * severe hypertriglyceridemia (\>400 mg/dL) * active peptic ulcer disease * diabetes * pregnant or lactating * take statins, fibrates, niacin, moderate to strong Cyp3A4 inhibitors or inducers, or any other medication that might confound interpretation of the study results will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| effect of Maraviroc on plasma triglyceride concentration | 12 weeks | We will compare pre and post-treatment serum triglyceride concentrations in subjects receiving a 12 week course of either Maraviroc or placebo. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Maraviroc on serum HDL concentration | 12 weeks | We will compare pre and post-treatment serum HDL concentrations in subjects receiving a 12 week course of either Maraviroc or placebo. |
| effect of Maraviroc on serum LDL-cholesterol concentration | 12 weeks | We will compare pre and post-treatment serum LDL-cholesterol concentrations in subjects receiving a 12 week course of either Maraviroc or placebo. |
| Effect of Maraviroc on plasma markers of cardiometabolic risk and inflammation | 12 weeks | We will compare pre and post-treatment plasma concentrations of C-reactive protein and InterLeukin-6 in subjects receiving a 12 week course of either Maraviroc or placebo. |
Countries
United States
Outcome results
None listed