Lipid Biomarker Study in Men With Dyslipidemia After Simvastatin Treatment (Study MK-0000-140)(COMPLETED)
A Randomized, Placebo Controlled Clinical Trial to Evaluate the Effects of Simvastatin Treatment on Measurements of Lipidomic Biomarkers in Men With Dyslipidemia
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Simvastatin 40 mg first, then placebo
Simvastatin 40 mg tablets once daily for 2 weeks followed by placebo for 2 weeks
|
40 mg once daily for 2 weeks
Autres noms:
Placebo, matching the simvastatin (40 mg) tablet as a single oral daily dose for 2 weeks
|
|
Comparateur placebo: Placebo first, then simvastatin 40 mg once daily
Placebo for 2 weeks followed by simvastatin 40 mg once daily for 2 weeks
|
40 mg once daily for 2 weeks
Autres noms:
Placebo, matching the simvastatin (40 mg) tablet as a single oral daily dose for 2 weeks
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Arachidonic Acid Level After 2 Weeks of Treatment
Délai: 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. |
2 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Fasting Blood Lipidomic Levels After 2 Weeks of Treatment
Délai: 2 weeks
|
Change in fasting blood cholesterol ester, lysophosphatidylcholine, phosphatidylcholine, phosphatidylethanolamine, and triacylglycerol levels compared to placebo. The mean reported was an adjusted mean. |
2 weeks
|
|
Serum Proprotein Convertase Subtilisin-like/Kexin Type 9 (PCSK9) Level
Délai: 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). |
2 weeks
|
|
Blood Linoleic Acid Levels
Délai: 2 weeks
|
Change in blood linoleic acid levels for Cholesterol Ester compared to placebo.
|
2 weeks
|
|
Change in Fasting Delta 5 Desaturase Enzyme Activity Compared to Placebo
Délai: 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.
|
2 weeks
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies métaboliques
- Troubles du métabolisme lipidique
- Hyperlipidémies
- Dyslipidémies
- Hypercholestérolémie
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs d'enzymes
- Antimétabolites
- Agents anticholestérolémiants
- Agents hypolipidémiants
- Agents de régulation des lipides
- Inhibiteurs de l'hydroxyméthylglutaryl-CoA réductase
- Simvastatine
Autres numéros d'identification d'étude
- 0000-140
- 2009_609
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Essais cliniques sur Simvastatin
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Centre hospitalier de l'Université de Montréal...Centre de Recherche du Centre Hospitalier de l'Université de MontréalRésilié