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

Type 2 Diabetes Clinical Trial

— LAAD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01494298
• Other study ID #: H1105110
• Status: Completed
• Phase: N/A
• First received: December 15, 2011
• Last updated: October 23, 2013
• Start date: December 2011
• Est. completion date: March 2013

Study information

• Verified date: October 2013
• Source: Mercer University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• African American
• Apolipoprotein
• Cholesterol
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Lipoprotein
• Type 2 Diabetes

Locations

Country	Name	City	State
United States	Grady Health System	Atlanta	Georgia
United States	Mercer Univeristy College of Pharmacy and Health Sciences	Atlanta	Georgia

Sponsors (4)

Lead Sponsor	Collaborator
Mercer University	Celera Genomics, Emory University, Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

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