Anti-inflammatory Agents and Cholesterol Metabolism
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|ClinicalTrials.gov Identifier: NCT01279395|
Recruitment Status : Recruiting
First Posted : January 19, 2011
Last Update Posted : January 29, 2018
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Impact of Anti-inflammatory Agents on Cholesterol Metabolism and Atherogenic Potency of Patient Plasma|
|Study Start Date :||November 2010|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||March 2018|
Patients age 40-70 who fulfill the American College of Rheumatology (ACR) criteria for a diagnosis of primary osteoarthritis are considered eligible. This group has been prescribed naproxen (1000 mg/day) for a minimum of two weeks.
Patients age 40-70 who fulfill the ACR criteria for a diagnosis of primary osteoarthritis. The group consists of patients who have been prescribed diclofenac (150 mg/day)for a minimum of two weeks.
Patients age 40-70 who fulfill the ACR criteria for a diagnosis of primary osteoarthritis are considered eligible. This group has been prescribed celecoxib (200 mg/day) for a minimum of two weeks.
- Difference in expression of the cholesterol-metabolizing enzyme cytochrome P450 cholesterol 27-hydroxylase in peripheral blood mononuclear cells (PBMC) before and after treatment with naprosyn, celecoxib or diclofenac. [ Time Frame: 2 weeks ]PBMC are isolated directly from patient blood by Ficoll hypaque gradient centrifugation. Total RNA is obtained (TriZol) from PBMC. 27-hydroxylase message is quantitated by quantitative real-time polymerase chain reaction (QRT-PCR) using specific primers.
- Difference in expression of cholesterol 27-hydroxylase in naive THP-1 human macrophages incubated in plasma from patients obtained before and after treatment with naprosyn, diclofenac or celecoxib. [ Time Frame: 2 weeks ]Comparison of abundance of the cholesterol-metabolizing enzyme cytochrome P450 cholesterol 27-hydroxylase in the THP-1 human monocyte/macrophage cell line incubated in plasma taken from the same patient before and after treatment with naprosyn, celecoxib or diclofenac. 27-hydroxylase message is quantitated by QRT-PCR and protein by immunoblot.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01279395
|Contact: Allison B Reiss, MDfirstname.lastname@example.org|
|United States, New York|
|Winthrop University Hospital||Recruiting|
|Mineola, New York, United States, 11501|
|Contact: Allison B Reiss, MD 516-663-3455 AReiss@winthrop.org|
|Contact: Betsy Pinnick, LPN 516-663-9582 BPinnick@winthrop.org|
|Principal Investigator:||Allison B Reiss, MD||Winthrop University Hospital|