Study of Cholesterol Levels and Types in African Americans With Type 2 Diabetes (LAAD)
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|ClinicalTrials.gov Identifier: NCT01494298|
Recruitment Status : Completed
First Posted : December 16, 2011
Results First Posted : December 13, 2013
Last Update Posted : December 13, 2013
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.
|Condition or disease|
|Type 2 Diabetes African American Cholesterol Lipoprotein Apolipoprotein|
|Study Type :||Observational|
|Actual Enrollment :||111 participants|
|Official 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|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
African-American men with type 2 diabetes who are not taking cholesterol-lowering medications.
African-American men without type 2 diabetes who are not taking cholesterol-lowering medications.
- ApoB Levels in African American Men With Diabetes and Those Without. [ Time Frame: At study entry ]Apolipoprotein B Age adjusted least square means are reported because of baseline differences in ages.
- LDL Density in African American Males With Diabetes and Those Without Diabetes [ Time Frame: 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. [ Time Frame: at study entry ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01494298
|United States, Georgia|
|Grady Health System|
|Atlanta, Georgia, United States, 30303|
|Mercer Univeristy College of Pharmacy and Health Sciences|
|Atlanta, Georgia, United States, 30341|