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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
| Emory University | OTHER |
| Celera Genomics | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T2DM | African-American men with type 2 diabetes who are not taking cholesterol-lowering medications. | ||
| Control | African-American men without type 2 diabetes who are not taking cholesterol-lowering medications. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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This is a cross-sectional epidemiologic study in which the lipoprotein subclasses, apolipoprotein levels, and genetic polymorphisms of African-American men with type 2 diabetes will be compared to African-American men without diabetes.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grady Health System | Atlanta | Georgia | 30303 | United States | ||
| Mercer Univeristy College of Pharmacy and Health Sciences |
1 subject was excluded from the diabetes group because he had type 1 diabetes
Exclusion from control group 1- was taking lipid lowering medications
1 - was not possible to do venous blood draw 5 - FBG between 100-126 mg/dL 2 - FBG>126 and were reassigned to diabetes group
Inclusion criteria were male gender, African American by self report and not taking of lipid-lowering medications. Subjects with diabetes were recruited from the Grady Diabetes Clinic in Atlanta, Georgia. Control subjects were recruited from the general Metro-Atlanta Area and had to have a fasting blood glucose <100 mg/dL.
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| ID | Title | Description |
|---|---|---|
| FG000 | T2DM | African American men with type 2 diabetes and not taking cholesterol-lowering medications. |
| FG001 | Controls | African American men without type 2 diabetes and not taking cholesterol-lowering medications. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The primary objective of this project was to determine the difference in Apo B levels in African-American men with and without diabetes.To achieve a power of 80%, 48 subjects in each group were needed to detect 15 mg/dL difference in ApoB levels, assuming a standard deviation of 26 mg/dL if alpha was set at 0.05.
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| ID | Title | Description |
|---|---|---|
| BG000 | T2DM | African American Men with Type 2 Diabetes |
| BG001 | Controls | African American Men without diabetes |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Least Squares Mean | Standard Error | mg/dL | At study entry |
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Since this was an observational study, serious and/or other non-serious adverse events were not collected/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | T2DM | African American men with type 2 diabetes and not taking cholesterol-lowering medications. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gina Ryan Clinical Professor | Mercer University College of Pharmacy | 678.547.6222 | ryan_gj@mercer.edu |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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We will retain a sample of serum, plasma and whole blood.
| Lipoprotein a [Lp(a)] in African Americans With Diabetes and Without. | at study entry |
| Atlanta |
| Georgia |
| 30341 |
| United States |
| BG002 |
| Total |
Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | 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 | Posted | Least Squares Mean | Standard Error | percentage of total LDL particles | at entry |
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| Secondary | Lipoprotein a [Lp(a)] in African Americans With Diabetes and Without. | Posted | Least Squares Mean | Standard Error | mg/dL | at study entry |
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| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Controls | African American men without type 2 diabetes and not taking cholesterol-lowering medications. | 0 | 0 | 0 | 0 |
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| D004700 | Endocrine System Diseases |
| LDL IIb |
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| LDL IIIa |
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| LDL IIIb |
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| LDL IVa |
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| LDL IVb |
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| LDL IIIa +b |
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