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

Sponsor
National Human Genome Research Institute (NHGRI) (NIH)
Overall Status
Recruiting
CT.gov ID
NCT01316783
Collaborator
(none)
1,100
Enrollment
1
Location

Study Details

Study Description

Brief Summary

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.

Condition or DiseaseIntervention/TreatmentPhase

    Detailed Description

    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, African ancestry) 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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Genetics of Obesity, Diabetes, and Heart Disease in African Diaspora Populations
    Actual Study Start Date :
    May 6, 2011

    Arms and Interventions

    ArmIntervention/Treatment
    Healthy Volunteers

    African ancestry and whites (who will serve as a comparison group)

    Outcome Measures

    Primary Outcome Measures

    1. Metabolic disorders [One study visit]

      type 2 diabetes, metabolic outcomes, dyslipidemia

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    • 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. 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.

    EXCLUSION CRITERIA:

    Family members are excluded to avoid biases in our analyses due to

    genomic similarities between family members. 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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1National Institutes of Health Clinical Center, 9000 Rockville PikeBethesdaMarylandUnited States20892

    Sponsors and Collaborators

    • National Human Genome Research Institute (NHGRI)

    Investigators

    • Principal Investigator: Charles N Rotimi, M.D., National Human Genome Research Institute (NHGRI)

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    National Human Genome Research Institute (NHGRI)
    ClinicalTrials.gov Identifier:
    NCT01316783
    Other Study ID Numbers:
    • 110110
    • 11-HG-0110
    First Posted:
    Mar 16, 2011
    Last Update Posted:
    Nov 3, 2021
    Last Verified:
    Jun 9, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Human Genome Research Institute (NHGRI)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 3, 2021