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NCT Number: NCT01494298

Study of Cholesterol Levels and Types 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.

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Key information

Age range

18 year–79 year

Sex eligibility

Male

Study type

Observational

Primary location

Grady Health System, Atlanta, Georgia, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. ApoB Levels in African American Men With Diabetes and Those Without.

    Time frame: At study entry

    Apolipoprotein B Age adjusted least square means are reported because of baseline differences in ages.

Secondary outcomes

  1. LDL Density in African American Males With Diabetes and Those Without Diabetes

    Time frame: 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

  2. Lipoprotein a [Lp(a)] in African Americans With Diabetes and Without.

    Time frame: at study entry

Sponsors and collaborators

Lead sponsor

Mercer University

Other

Collaborators

  • Celera Genomics
  • Emory University
  • Merck Sharp & Dohme LLC

Registry information

Official study 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

Acronym: LAAD

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 16, 2011
Registry last updated
Dec 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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