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临床试验/NCT01494298
NCT01494298已完成不适用

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

Mercer University2 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2011年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
111
试验地点
2
主要终点
ApoB Levels in African American Men With Diabetes and Those Without.

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 79 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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%.

排除标准

  • Self report of race or ethnicity other than African
  • Currently taking any lipid-lowering medications

结局指标

主要结局

ApoB Levels in African American Men With Diabetes and Those Without.

时间窗: At study entry

Apolipoprotein B Age adjusted least square means are reported because of baseline differences in ages.

次要结局

  • Lipoprotein a [Lp(a)] in African Americans With Diabetes and Without.(at study entry)
  • LDL Density in African American Males With Diabetes and Those Without Diabetes(at entry)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gina J. Ryan

Clinical Associate Professor

Mercer University

研究点 (2)

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