Clinical trial NCT01494298: Study of Cholesterol Levels and Types in African Americans With Type 2 Diabetes
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
African American
Cholesterol
Lipoprotein
Apolipoprotein
Keywords: Type 2 diabetes
African American
cholesterol
lipoprotein
apolipoprotein
Lead sponsor: Mercer University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: Emory University
name: Celera Genomics
First posted: 2011-12-16
Enrollment: 111
Sex: MALE
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This is a cross-sectional epidemiologic study in which the lipoprotein subclasses, apolipoprotein levels, and genetic polymorphisms of African-American men with type 2 diabetes will be compared to African-American men without diabetes.

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.


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

Primary outcomes:
measure: ApoB Levels in African American Men With Diabetes and Those Without.
timeFrame: At study entry
Secondary outcomes:
measure: LDL Density in African American Males With Diabetes and Those Without Diabetes
timeFrame: at entry
measure: Lipoprotein a [Lp(a)] in African Americans With Diabetes and Without.
timeFrame: at study entry
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
city: Atlanta
country: United States
facility: Mercer Univeristy College of Pharmacy and Health Sciences
state: Georgia
Study officials:
References: