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

NCT01494298 | Completed Results

• 1 other identifier: H1105110
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Type 2 Diabetes; African American; Cholesterol; Lipoprotein; Apolipoprotein

Keywords

Type 2 diabetes; African American; cholesterol; lipoprotein; apolipoprotein

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• LDL Density in African American Males With Diabetes and Those Without Diabetes

  at entry

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

  at study entry

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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%.

You may not qualify if:

• Females
• Self report of race or ethnicity other than African
• Currently taking any lipid-lowering medications

Sponsors & Collaborators

• Mercer University: lead
• Merck Sharp & Dohme LLC: collaborator
• Emory University: collaborator
• Celera Genomics: collaborator

Study Sites (2)

Grady Health System

Atlanta, Georgia, 30303, United States

Location

Mercer Univeristy College of Pharmacy and Health Sciences

Atlanta, Georgia, 30341, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Gina Ryan Clinical Professor
• Organization: Mercer University College of Pharmacy

ryan_gj@mercer.edu

678.547.6222

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: December 15, 2011
• First Posted: December 16, 2011
• Study Start: December 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: December 13, 2013
• Results First Posted: December 13, 2013

Record last verified: 2013-10

Locations

US (2)