Study of Cholesterol Levels and Types in African Americans With Type 2 Diabetes (LAAD)
Preliminary Analysis of Lipoprotein Subclasses, Apoprotein Levels, and Genetic Architecture of African-American Males With Type 2 Diabetes. Lipids in African Americans With Type 2 Diabetes
Compared to other races, African-Americans with type 2 diabetes have different cholesterol levels, specifically triglycerides and low density lipoprotein. Recent data has shown the not only are cholesterol levels important in determining the risk for cardiovascular disease, but the size of the cholesterol particles and surface proteins on the cholesterol particles are also important. The objective of this study is to determine if African-American males with diabetes have different particle size, surface proteins, and cholesterol genetic links than African-American male without diabetes and Caucasian-American males with and without diabetes.
African-American males with type 2 diabetes and not taking lipid-lowering medications are the current target population.
After obtaining an informed consent, a complete medical history will be obtained and subjects will be examined, noninvasively, for physical signs of elevated cholesterol levels. Afterwards, blood samples [one venous puncture, 6 tubes (21 mL total)] will be obtained. Blood samples will be coded, sent to Berkeley Heart Lab and/or Clinical Laboratory Services, and undergo genetic testing at Mercer University College of Pharmacy and Health Sciences.
Confidentiality of the subjects will be explained in the consenting process to the subjects. All subject samples and information will be coded. Each subject will be given a subject number upon consenting and this will be used throughout the study. All pertinent information of the subjects will be listed under the designated number, but will not be associated with that patient.
調査の概要
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Georgia
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Atlanta、Georgia、アメリカ、30303
- Grady Health System
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Atlanta、Georgia、アメリカ、30341
- Mercer Univeristy College of Pharmacy and Health Sciences
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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
Inclusion Criteria:
- Male
- African American by self-report
- Subjects will be defined as having diabetes if they are diagnosed with diabetes per the American Diabetes Association guidelines
- Subjects without diabetes or impaired glucose tolerance will have a fasting blood glucose <100 mg/dL and/or glycosylated hemoglobin(A1C) <6.5%.
Exclusion Criteria:
- Females
- Self report of race or ethnicity other than African
- Currently taking any lipid-lowering medications
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
コホートと介入
グループ/コホート |
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T2DM
African-American men with type 2 diabetes who are not taking cholesterol-lowering medications.
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Control
African-American men without type 2 diabetes who are not taking cholesterol-lowering medications.
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
ApoB Levels in African American Men With Diabetes and Those Without.
時間枠:At study entry
|
Apolipoprotein B Age adjusted least square means are reported because of baseline differences in ages.
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At study entry
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
LDL Density in African American Males With Diabetes and Those Without Diabetes
時間枠:at entry
|
LDL size subclassification was divided into the following groups (from largest size to smallest size): LDL I, LDL IIa, LDL IIb, LDL IIIa, LDL IIIb, LDL IVa, LDL IVa, and LDL IVb. For differences posted P<0.05 for LDL I, LDL IIb, LDL IIIa, and LDL IIIa +b |
at entry
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Lipoprotein a [Lp(a)] in African Americans With Diabetes and Without.
時間枠:at study entry
|
at study entry
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協力者と研究者
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。