N/A Completed N=20 Randomized Triple-blind Basic Science

To Study the Effect of Vytorin on Intracellular Lipid and Inflammation in Obese Subjects

Inflammation

Source: ClinicalTrials.gov NCT01420328 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2024

Primary outcomePrimary: Change in CD68 mRNA Expression in MNC — 10; -68 percentage of change

Summary

This study focuses on the use of Vytorin to study inflammatory markers in subjects with normal cholesterol.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in CD68 mRNA Expression in MNC	10; -68	—
SECONDARY Change in Cream-induced Expression of CD16	-10; -57	—
SECONDARY Change IL-1b mRNA Expression	-13; -74	—
SECONDARY Change in Plasma Endotoxin (LPS) Concentrations	0.11; -0.23	—

Eligibility Criteria

Inclusion Criteria

Age 18-65years.
Obese BMI >30kg/m2
LDL cholesterol >100 mg/dl
Written and informed consent signed and dated 5. Not on any vitamin/antioxidants

Exclusion Criteria

On any antilipid agents.
Triglyceride >500mg/dl
Myocardial infarction, angioplasty/stent placement or coronary artery bypass surgery in the past 6 months
Patient on chronic use of non-steroidal anti-inflammatory drugs or steroids
Hepatic disease
Renal impairment
History of drug or alcohol abuse
Participation in any other concurrent clinical trial
Use of an investigational agent or therapeutic regimen within 30 days of study.
Smoker
Pregnancy
Premenopausal women who are not on birth control pills and have not had a hysterectomy or tubal ligation 13. Anemia with hemoglobin <12 g/dl

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01420328). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.