This trial is active, not recruiting.

Condition inflammation
Treatment vytorin
Phase phase 3
Sponsor Kaleida Health
Start date May 2011
End date December 2013
Trial size 20 participants
Trial identifier NCT01420328, MED7120311A


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Placebo Comparator)
Obese subjects with near normal cholesterol
vytorin Ezetimibi/Simvastatin 10/40
Simvastatin 40 mg and Ezetimibe 10 mg daily combination pill (Vytorin
(Active Comparator)
Obese subjects with near normal cholesterol
vytorin Ezetimibi/Simvastatin 10/40
Simvastatin 40 mg and Ezetimibe 10 mg daily combination pill (Vytorin

Primary Outcomes

Change in nile red staining score
time frame: 6 weeks

Secondary Outcomes

Change in markers of monocyte activation
time frame: 6 weeks
Change in markers of inflammation
time frame: 6 weeks
Change in the expression of toll like receptor
time frame: 6 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: 1. Age 18-65years. 2. Obese BMI >30kg/m2 3. LDL cholesterol >100 mg/dl 4. Written and informed consent signed and dated 5. Not on any vitamin/antioxidants Exclusion Criteria: 1. On any antilipid agents. 2. Triglyceride >500mg/dl 3. Myocardial infarction, angioplasty/stent placement or coronary artery bypass surgery in the past 6 months 4. Patient on chronic use of non-steroidal anti-inflammatory drugs or steroids 5. Hepatic disease 6. Renal impairment 7. History of drug or alcohol abuse 8. Participation in any other concurrent clinical trial 9. Use of an investigational agent or therapeutic regimen within 30 days of study. 10. Smoker 11. Pregnancy 12. 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

Additional Information

Official title To Study the Effect of Vytorin on Intracellular Lipid and Inflammation in Obese Subjects
Principal investigator Paresh Dandona, MD
Description Following the first demonstration by our group that macronutrient (glucose, cream and a high fat high carbohydrate meal) intake results in increased ROS generation and oxidative stress at the cellular and molecular level, the investigators have now shown in our preliminary data that cream intake induces comprehensive inflammation as reflected in increased intranuclear NFkB binding, decreased IkBα expression, increased expression of IL-1β, IL-12, TNFα and other pro-inflammatory mediators. While carrying out these experiments, the investigators asked whether cream intake was associated with an uptake of lipid by peripheral blood mononuclear cells (MNC). Indeed, there was a significant increase in intracellular lipid which was visualized as intracellular lipid droplets. The increase in intracellular lipid droplets was associated with an increase in intracellular superoxide generation; the expression of CD68, a marker for macrophages; and PECAM, the adhesion molecule which mediates trans- endothelial transfer of leucocytes. The investigators also found that the lipid fractions to increase were cholesterol ester, triglyceride and fatty acids. In view of the tantalizing observation that the lipid droplet laden MNC appeared to be monocytes, looked like foam cells and the fact that CD68 expression had increased, there is a possibility that foam cells may be formed in peripheral circulation by monocytes after a lipid rich meal. This simple model of foam cell formation also lends itself for the study of the effect of various lipid lowering drugs. Our investigation will be the first to study this novel paradigm. The investigators plan to study the effect of a cholesterol lowering agent, Vytorin (simvastatin and ezetimibe), on intracellular lipid in MNC, expression of CD68 and PECAM, ROS generation and inflammation in obese subjects. This investigation may provide an additional mechanism of action by which these drugs may reduce atherosclerosis.
Trial information was received from ClinicalTrials.gov and was last updated in December 2012.
Information provided to ClinicalTrials.gov by Kaleida Health.