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ClinicalIndex Comparison Record
N/ACompleted· 111 enrolled
Drug / intervention
Not specified
Likely dose
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Search/NCT01494298
NCT01494298N/ACompleted

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

Mercer University·observational·Posted Dec 16, 2011·Updated Dec 13, 2013

In Brief

An observational study for Type 2 Diabetes and 4 related conditions. Completed, enrolled 111 participants across 2 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 16, 2011
Enrollment StartDec 1, 2011
Primary CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.5 years ago