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