African American, Apolipoprotein, Cholesterol, Lipoprotein, Type 2 Diabetes
Conditions
Keywords
Type 2 diabetes, African American, cholesterol, lipoprotein, apolipoprotein
Brief summary
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.
Interventions
None listed
Sponsors
Merck Sharp & Dohme LLC
Emory University
Celera Genomics
Mercer University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ApoB Levels in African American Men With Diabetes and Those Without. | At study entry | Apolipoprotein B Age adjusted least square means are reported because of baseline differences in ages. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LDL Density in African American Males With Diabetes and Those Without Diabetes | 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 |
| Lipoprotein a [Lp(a)] in African Americans With Diabetes and Without. | at study entry | — |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| T2DM African American Men with Type 2 Diabetes | 54 |
| Controls African American Men without diabetes | 47 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 2 | 8 |
Baseline characteristics
| Characteristic | T2DM | Total | Controls |
|---|---|---|---|
| Age Continuous | 52 Years STANDARD_DEVIATION 8 | 48.5 Years STANDARD_DEVIATION 11.3 | 44.5 Years STANDARD_DEVIATION 13.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 54 Participants | 101 Participants | 47 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 54 participants | 101 participants | 47 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 54 Participants | 101 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: At study entry
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| T2DM | ApoB Levels in African American Men With Diabetes and Those Without. | 80 mg/dL | Standard Error 3 |
| Controls | ApoB Levels in African American Men With Diabetes and Those Without. | 65 mg/dL | Standard Error 3 |
Comparison: Hypothesis - There will be differences in ApoB between AA with T2DM and those without. 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. Continuous data were compared using a Students t-test and categorical data were compared using test.p-value: =0.002t-test, 2 sided
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
Time frame: at entry
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| T2DM | LDL Density in African American Males With Diabetes and Those Without Diabetes | LDL I | 21 percentage of total LDL particles | Standard Error 1 |
| T2DM | LDL Density in African American Males With Diabetes and Those Without Diabetes | LDL IIa | 24 percentage of total LDL particles | Standard Error 1 |
| T2DM | LDL Density in African American Males With Diabetes and Those Without Diabetes | LDL IIb | 29 percentage of total LDL particles | Standard Error 1 |
| T2DM | LDL Density in African American Males With Diabetes and Those Without Diabetes | LDL IIIa | 18 percentage of total LDL particles | Standard Error 1 |
| T2DM | LDL Density in African American Males With Diabetes and Those Without Diabetes | LDL IIIb | 3.3 percentage of total LDL particles | Standard Error 0.3 |
| T2DM | LDL Density in African American Males With Diabetes and Those Without Diabetes | LDL IVa | 2.8 percentage of total LDL particles | Standard Error 0.2 |
| T2DM | LDL Density in African American Males With Diabetes and Those Without Diabetes | LDL IVb | 1.4 percentage of total LDL particles | Standard Error 0.1 |
| T2DM | LDL Density in African American Males With Diabetes and Those Without Diabetes | LDL IIIa +b | 21 percentage of total LDL particles | Standard Error 2 |
| Controls | LDL Density in African American Males With Diabetes and Those Without Diabetes | LDL IIIa +b | 16 percentage of total LDL particles | Standard Error 2 |
| Controls | LDL Density in African American Males With Diabetes and Those Without Diabetes | LDL I | 29 percentage of total LDL particles | Standard Error 1 |
| Controls | LDL Density in African American Males With Diabetes and Those Without Diabetes | LDL IIIb | 3.4 percentage of total LDL particles | Standard Error 0.3 |
| Controls | LDL Density in African American Males With Diabetes and Those Without Diabetes | LDL IIa | 27 percentage of total LDL particles | Standard Error 1 |
| Controls | LDL Density in African American Males With Diabetes and Those Without Diabetes | LDL IVb | 1.3 percentage of total LDL particles | Standard Error 0.1 |
| Controls | LDL Density in African American Males With Diabetes and Those Without Diabetes | LDL IIb | 24 percentage of total LDL particles | Standard Error 1 |
| Controls | LDL Density in African American Males With Diabetes and Those Without Diabetes | LDL IVa | 2.8 percentage of total LDL particles | Standard Error 0.2 |
| Controls | LDL Density in African American Males With Diabetes and Those Without Diabetes | LDL IIIa | 13 percentage of total LDL particles | Standard Error 1 |
Secondary
Lipoprotein a [Lp(a)] in African Americans With Diabetes and Without.
Time frame: at study entry
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| T2DM | Lipoprotein a [Lp(a)] in African Americans With Diabetes and Without. | 43 mg/dL | Standard Error 5 |
| Controls | Lipoprotein a [Lp(a)] in African Americans With Diabetes and Without. | 45 mg/dL | Standard Error 5 |
p-value: 0.84t-test, 2 sided