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

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

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 Overview

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

• Study Type: Observational
• Enrollment (Actual): 111

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Grady Health System
    • Atlanta, Georgia, United States, 30341
      • Mercer Univeristy College of Pharmacy and Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
T2DM; African-American men with type 2 diabetes who are not taking cholesterol-lowering medications.
Control; African-American men without type 2 diabetes who are not taking cholesterol-lowering medications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Lipoprotein a [Lp(a)] in African Americans With Diabetes and Without.		at study entry

Collaborators and Investigators

• Sponsor: Mercer University
• Collaborators: Merck Sharp & Dohme LLC; Emory University; Celera Genomics

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: December 15, 2011
• First Submitted That Met QC Criteria: December 15, 2011
• First Posted (Estimate): December 16, 2011

Study Record Updates

• Last Update Posted (Estimate): December 13, 2013
• Last Update Submitted That Met QC Criteria: October 23, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Type 2 diabetes; African American; cholesterol; lipoprotein; apolipoprotein
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: H1105110