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
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
- 否
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
Gina J. Ryan
Clinical Associate Professor
Mercer University
