Study of Cholesterol Levels and Types in African Americans With Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Type 2 Diabetes, African American, Cholesterol, Lipoprotein, Apolipoprotein

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| T2DM<br>African-American men with type 2 diabetes who are not taking cholesterol-lowering medications. | |
| Control<br>African-American men without type 2 diabetes who are not taking cholesterol-lowering medications. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ApoB Levels in African American Men With Diabetes and Those Without. | Apolipoprotein B Age adjusted least square means are reported because of baseline differences in ages. | At study entry | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL Density in African American Males With Diabetes and Those Without Diabetes | 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 | 
| Lipoprotein a [Lp(a)] in African Americans With Diabetes and Without. |  | at study entry | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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African American, cholesterol, lipoprotein, apolipoprotein, Type 2 diabetes