Protocol Details

Genetics of Obesity, Diabetes, and Heart Disease in African Diaspora Populations

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number	11-HG-0110
Sponsoring Institute	National Human Genome Research Institute (NHGRI)
Recruitment Detail	Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 18 Max Age: N/A
Referral Letter Required	Yes
Population Exclusion(s)	Children; American Indian or Alaskan Native; Asian; White (Not of Hispanic Origin); Hispanic; Pacific Islander
Special Instructions	Currently Not Provided
Keywords	Africans; Obesity; Diabetes; Heart Disease; Genetic
Recruitment Keyword(s)	African Descent; Cardiovascular Disease; Diabetes
Condition(s)	Diabetes; Cardiovascular Disease
Investigational Drug(s)	None
Investigational Device(s)	None
Intervention(s)	None
Supporting Site	National Human Genome Research Institute

Background:

- 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.

Objectives:

- 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.

Eligibility:

- Individuals at least 18 years of age who self-identify as African American, Afro-Caribbean, or migrants from sub Saharan Africa.

Design:

- Participants will undergo a physical examination and will provide a blood sample for study.

- Participants will also answer questions about personal and family medical history and current lifestyle behaviors.

- No treatment will be provided as part of this protocol.

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Eligibility

INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

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.

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Citations:

Li B, Leal SM. Methods for detecting associations with rare variants for common diseases: application to analysis of sequence data. Am J Hum Genet. 2008 Sep;83(3):311-21. Epub 2008 Aug 7.

Wolf SM, Lawrenz FP, Nelson CA, Kahn JP, Cho MK, Clayton EW, Fletcher JG, Georgieff MK, Hammerschmidt D, Hudson K, Illes J, Kapur V, Keane MA, Koenig BA, Leroy BS, McFarland EG, Paradise J, Parker LS, Terry SF, Van Ness B, Wilfond BS. Managing incidental findings in human subjects research: analysis and recommendations. J Law Med Ethics. 2008 Summer;36(2):219-48, 211.

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Contacts:

Principal Investigator	Referral Contact	For more information:
Charles N. Rotimi, M.D. National Human Genome Research Institute (NHGRI) National Institutes of Health Building 12A Room 4047 12 South Drive Bethesda, Maryland 20892 (301) 451-2303 rotimic@mail.nih.gov	Shirley Freeman National Human Genome Research Institute (NHGRI) National Institutes of Health Building 12A Room 4047 12 South Drive Bethesda, Maryland 20892 (301) 451-2302 freemansh@mail.nih.gov	Patient Recruitment and Public Liaison Office Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT01316783

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