Type 2 Diabetes Clinical Trial
— LAADOfficial title:
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
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.
Status | Completed |
Enrollment | 111 |
Est. completion date | March 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 79 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Grady Health System | Atlanta | Georgia |
United States | Mercer Univeristy College of Pharmacy and Health Sciences | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Mercer University | Celera Genomics, Emory University, Merck Sharp & Dohme Corp. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | At study entry | No |
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 |
at entry | No |
Secondary | Lipoprotein a [Lp(a)] in African Americans With Diabetes and Without. | at study entry | No |
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