Status:
COMPLETED
To Study the Effect of Vytorin on Intracellular Lipid and Inflammation in Obese Subjects
Lead Sponsor:
University at Buffalo
Collaborating Sponsors:
Kaleida Health
Conditions:
Inflammation
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This study focuses on the use of Vytorin to study inflammatory markers in subjects with normal cholesterol.
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01420328
Start Date
May 1 2011
End Date
July 1 2016
Last Update
April 17 2024
Active Locations (1)
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1
Diabetes Endocrinology Center of WNY
Buffalo, New York, United States, 14209