Study of Cholesterol Levels and Types in African Americans With Type 2 Diabetes

Completed

• Conditions: Lipoprotein; African American; Apolipoprotein; Type 2 Diabetes; Cholesterol

• Registration Number: NCT01494298
• Lead Sponsor: Mercer University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-15
• Study First Submitted QC: 2011-12-15
• Study First Posted: 2011-12-16
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Results First Submitted: 2013-06-19
• Status Verified: 2013-10
• Results First Submitted QC: 2013-10-23
• Last Update Submitted: 2013-10-23
• Results First Posted: 2013-12-13
• Last Update Posted: 2013-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 111

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ApoB Levels in African American Men With Diabetes and Those Without.	At study entry	Apolipoprotein B Age adjusted least square means are reported because of baseline differences in ages.

Secondary Outcome Measures

Name	Time	Method
Lipoprotein a [Lp(a)] in African Americans With Diabetes and Without.	at study entry
LDL Density in African American Males With Diabetes and Those Without Diabetes	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

Trial Locations

Locations (2)

Grady Health System; 🇺🇸 Atlanta, Georgia, United States

Mercer Univeristy College of Pharmacy and Health Sciences; 🇺🇸 Atlanta, Georgia, United States