Lipid Biomarker Study in Men With Dyslipidemia After Simvastatin Treatment (Study MK-0000-140)(COMPLETED)
- Conditions
- Hypercholesterolemia, Dyslipidemia
- Interventions
- Drug: Placebo
- Registration Number
- NCT00935259
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this study was to provide human lipidomics standards with simvastatin treatment that were to be used for comparison with similar preclinical studies.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 31
- Participant is a Caucasian (including Hispanic) male
- Participant has a maximum waist size of 40 inches
- Participant does not currently use any lipid-altering medications
- Participant is in good health other than the diagnosis of dyslipidemia
- Participant has had stomach ulcers within the last 3 months
- Participant has had a heart attack in the last 6 months or has angina
- Participant has chronic heart failure
- Participant has a history of stroke, seizures, or major neurological disorder
- Participant has a history of cancer
- Participant has a gastrointestinal condition that affects bowel movements
- Participant has type 1 or 2 diabetes
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Simvastatin 40 mg first, then placebo Simvastatin Simvastatin 40 mg tablets once daily for 2 weeks followed by placebo for 2 weeks Simvastatin 40 mg first, then placebo Placebo Simvastatin 40 mg tablets once daily for 2 weeks followed by placebo for 2 weeks Placebo first, then simvastatin 40 mg once daily Placebo Placebo for 2 weeks followed by simvastatin 40 mg once daily for 2 weeks Placebo first, then simvastatin 40 mg once daily Simvastatin Placebo for 2 weeks followed by simvastatin 40 mg once daily for 2 weeks
- Primary Outcome Measures
Name Time Method Arachidonic Acid Level After 2 Weeks of Treatment 2 weeks Arachidonic acid level (20:4n6) in the cholesterol ester lipid class.
The mean reported was an adjusted mean, which was obtained from running a 2-period crossover model that had fixed treatment and period terms and a random participant term.
- Secondary Outcome Measures
Name Time Method Blood Linoleic Acid Levels 2 weeks Change in blood linoleic acid levels for Cholesterol Ester compared to placebo.
Change in Fasting Delta 5 Desaturase Enzyme Activity Compared to Placebo 2 weeks Change in fasting delta 5 desaturase enzyme activity compared to placebo. Delta 5 desaturase enzyme activity is defined as the ratios of C20:4n-6 to C20:3n-6 and C20:5n-3 to C20:4n-3.
Serum Proprotein Convertase Subtilisin-like/Kexin Type 9 (PCSK9) Level 2 weeks Two days of standardized, pre-packaged meals were provided prior to the 10-hour fast required before blood collection. To assess how consumption of a meal would affect levels of plasma PCSK9, following each of the fasting blood draws, participants were asked to consume a high fat meal (heavy whipping cream + vanilla ice cream in a 1:4 ratio \[dose = 162 g/m\^2\]) within 20 minutes. For the duration of the test, participants were to remain seated or recumbent until blood samples were drawn 4 h after meal completion.
The mean reported was an adjusted mean (defined in first outcome measure).Fasting Blood Lipidomic Levels After 2 Weeks of Treatment 2 weeks Change in fasting blood cholesterol ester, lysophosphatidylcholine, phosphatidylcholine, phosphatidylethanolamine, and triacylglycerol levels compared to placebo.
The mean reported was an adjusted mean.