Pharmacogenetics of Hypertriglyceridemia in Hispanics
調査の概要
状態
条件
詳細な説明
BACKGROUND:
Increased serum triglycerides are a significant independent risk factor for coronary artery disease and myocardial infarction. Besides typical lifestyle modification, the treatment with fibrates is standard in patients with hypertriglyceridemia. There is ample evidence that genetic factors influence triglyceride levels. Identifying genes, which affect triglyceride levels and moreover determining the response to fibrates is of great interest. Hispanics are among the populations with the highest prevalence of this disease. Therefore focusing on a high-risk population further adds to the overall significance of this study. Identifying genes and genetic mechanisms contributing to the treatment response can lead to new or improved treatment methods.
DESIGN NARRATIVE:
The study tests the hypothesis that differences in therapeutic effects of fibrates are related to variations in networks of genes regulating lipoprotein metabolism. An efficient approach for identifying and categorizing major gene variants is based on determination of sequence haplotypes. Only Hispanics will be studied to provide a homogenous population for this genetic study. Furthermore, Hispanics are the fastest growing ethnic group in the U.S. and have a higher prevalence of hypertriglyceridemia than other ethnic groups. The investigators will measure plasma triglycerides (TG), other lipids and lipoproteins, and lipoprotein particle size before and after treatment with fenofibrate in 800 Hispanic individuals with hypertriglyceridemia. They will reconstruct the haplotypes of 16 candidate genes known to regulate TG metabolism and mediate the effect of fibrates. The associations between phenotypes and major haplotypes will be analyzed in a two stage design, with the first half of the sample serving a hypothesis-generating function. Those candidate gene haplotypes that are found to be associated with quantitative traits and drug responses in the first half of the sample will then be tested for confirmation in the second half. In addition, data from the full cohort will be analyzed to identify additional pharmacogenetic associations that may require greater statistical power. Finally, direct fine mapping will be performed in the four most promising genes to identify the responsible variations.
研究の種類
入学 (実際)
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
研究計画
研究はどのように設計されていますか?
デザインの詳細
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
---|---|
Plasma triglycerides
時間枠:1 month
|
1 month
|
協力者と研究者
捜査官
- 主任研究者:Stanley Korenman, MD、University of California, Los Angeles
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
心臓疾患の臨床試験
-
Novartis Pharmaceuticals完了EC-MPS による治療に関心があり、コア研究の 12 か月の治療期間を無事に完了した患者 (de novo Heart Recipients)