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

This study is currently recruiting participants.
Verified October 2012 by Mercer University
Sponsor:
Collaborators:
Study funded by Merck, Inc
Emory University
H. Robert Superko, M.D., Vice President, Chief of Medical Affairs Celera
Information provided by (Responsible Party):
Gina J. Ryan, Mercer University
ClinicalTrials.gov Identifier:
NCT01494298
First received: December 15, 2011
Last updated: October 31, 2012
Last verified: October 2012
  Purpose

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. The results of their lab analysis will be compared to results from a previous study conducted by Dr. Momary, a co-investigator,that included African-American men without diabetes and Caucasian men with and without diabetes.

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.


Condition
Type 2 Diabetes
African American
Cholesterol
Lipoprotein
Apolipoprotein

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Mercer University:

Secondary Outcome Measures:
  • Differences in lipoprotein a [Lp(a)] in African American males with diabetes and those without diabetes
  • Differences in nonHDL levels in African American males with diabetes and those without diabetes

Biospecimen Retention:   Samples With DNA

We will retain a sample of serum, plasma and whole blood.


Estimated Enrollment: 200
Groups/Cohorts
African American males with type 2 diabetes

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

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 an A1C<6.5%.

Exclusion Criteria:

  • Females
  • Self report of race or ethnicity other than African
  • Currently taking any lipid-lowering medications
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01494298

Locations
United States, Georgia
Mercer Univeristy College of Pharmacy and Health Sciences Recruiting
Atlanta, Georgia, United States, 30341
Contact: Gina J Ryan, PharmD     678-547-6222     ryan_gj@mercer.edu    
Principal Investigator: Gina Ryan, PharmD            
Grady Health System Recruiting
Atlanta, Georgia, United States, 30303
Contact: Gina J Ryan, PharmD     404-616-3749     ryan_gj@mercer.edu    
Principal Investigator: Gina J Ryan, PharmD            
Sponsors and Collaborators
Mercer University
Study funded by Merck, Inc
Emory University
H. Robert Superko, M.D., Vice President, Chief of Medical Affairs Celera
  More Information

No publications provided

Responsible Party: Gina J. Ryan, Clinical Associate Professor, Mercer University
ClinicalTrials.gov Identifier: NCT01494298     History of Changes
Other Study ID Numbers: H1105110
Study First Received: December 15, 2011
Last Updated: October 31, 2012
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Mercer University:
Type 2 diabetes
African American
cholesterol
lipoprotein
apolipoprotein

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 22, 2013