Genetics of Obesity, Diabetes, and Heart Disease in African Diaspora Populations
|First Received Date ICMJE||March 15, 2011|
|Last Updated Date||July 24, 2015|
|Start Date ICMJE||March 2011|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01316783 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Genetics of Obesity, Diabetes, and Heart Disease in African Diaspora Populations|
|Official Title ICMJE||Genetics of Obesity, Diabetes, and Heart Disease in African Diaspora Populations|
- African Americans have one of the highest rates of type 2 diabetes in the United States, and often have other medical problems related to obesity and cardiovascular disease. These conditions have various risk factors, including high blood sugar levels, high cholesterol levels, and insulin resistance. However, these risk factors have not been studied very closely in individuals with African ancestry, including Afro-Caribbean and sub-Saharan Africa migrant populations. Researchers are interested in conducting a genetic study on obesity, adult-onset diabetes, heart disease, and other common health conditions in individuals with African ancestry.
- To collect genetic and non-genetic information from individuals with African ancestry to study common health conditions related to obesity, adult-onset diabetes, and heart disease.
- Individuals at least 18 years of age who self-identify as African American, Afro-Caribbean, or migrants from sub Saharan Africa.
This research protocol is designed to study the genetic basis of the clustering of several metabolic disorders including Type 2 diabetes (T2D), hypertension, cardiovascular diseases (CVD), obesity, and other related conditions in populations of the African Diaspora. This project takes advantage of the well-established infrastructure and success of Dr. Anne Sumner s NIDDK clinical protocols. The project will aim to enroll subjects from her cohorts which include whites, African Americans and Africans living in the United States with the goal of performing quantitative trait analysis using a candidate gene approach to understand the genetic basis of serum lipid levels, blood pressure, fasting glucose, and other metabolic parameters. For aim 2, we propose to perform whole exome sequencing in a subset of cases (n=48, 96 chromosomes) to identify both rare and common variants for multiple metabolic parameters. Variants identified by the exome sequencing effort and by a current sequencing project of six candidate lipid genes will be genotyped in the entire cohort. Overall, these studies will further efforts to understand if black-white differences as well as differences within black populations exist in the genetic basis of T2D, CVD, and obesity. Given past activities, it is also anticipated that this resource will form the basis of multiple collaborations between Dr. Rotimi s lab, several NIH intramural researchers, and non-NIH scientists.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Enrolling by invitation|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Subjects will include unrelated persons who self-identify as white or African American, Afro-Caribbean or migrant from sub-Saharan Africa. Adults of African ancestry are prioritized for this study because of the paucity of genetics studies investigating the association of risk alleles contributing to the prevalence of T2D, CVD, obesity and other common conditions in this population. A small proportion of whites (less than 10%) will be included in this study, as they are in Dr. Sumner s ongoing projects; they will have the same clinical measurements obtained in the same laboratory to serve as a comparison group.
Children are excluded as these phenotypes present more commonly in adults. Attempts will be made to enroll an equal number of men and women. No prisoners, pregnant women or fetuses will be included in this study.
|Ages||18 Years and older|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT01316783|
|Other Study ID Numbers ICMJE||110110, 11-HG-0110|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) )|
|Study Sponsor ICMJE||National Human Genome Research Institute (NHGRI)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||July 2015|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP