N/A
Completed N=111
Study of Cholesterol Levels and Types in African Americans With Type 2 Diabetes
Type 2 Diabetes · African American · Cholesterol · Lipoprotein
Source: ClinicalTrials.gov NCT01494298 ↗
Enrolled (actual)
111
Serious AEs
—
Results posted
Dec 2013
Primary outcomePrimary: ApoB Levels in African American Men With Diabetes and Those Without. — 80; 65 mg/dL — p==0.002
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ApoB Levels in African American Men With Diabetes and Those Without. |
80; 65 | =0.002 sig |
| SECONDARY LDL Density in African American Males With Diabetes and Those Without Diabetes |
21; 29; 24; 27; 29; 24 | — |
| SECONDARY Lipoprotein a [Lp(a)] in African Americans With Diabetes and Without. |
43; 45 | 0.84 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01494298). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.