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

NCT01316783 | Enrolling By Invitation

• 2 other identifiers: 11011011-HG-0110
• Study Type: observational
• Target: 1,100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Cardiovascular Disease

Keywords

Cardiometabolic Diseases; Natural History

Outcome Measures

Primary Outcomes (1)

• Metabolic disorders

  type 2 diabetes, metabolic outcomes, dyslipidemia

  One study visit

Study Arms (1)

Healthy Volunteers

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

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The estimated number of participants is 1100 with 100 of those being white participants. Based on Dr. Sumner's previous work with these cohorts, we expect 25% of the African Ancestry populations to have abnormal glucose tolerance or diabetes, 50 percent to be obese, and 20% to be hypertensive. For whites the % frequency will be lower. The power analysis is based on black populations, the focus of the study. The enrollment ceiling is 1100 and the anticipated enrollment by year is 100 individuals.

You may qualify if:

• Persons who self-identify as either
• African American
• Afro-Caribbean
• A migrant from sub-Saharan Africa
• White
• Persons \>= 18 years
• Participation in a protocol with Dr. Anne Sumner, NIDDK

You may not qualify if:

• Individuals related to participants (any known familial relationship, as reported by the prospective enrollee)
• Adults unable to consent
• Pregnant women

Sponsors & Collaborators

• National Human Genome Research Institute (NHGRI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Diabetes Mellitus; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Charles N Rotimi, M.D.

  National Human Genome Research Institute (NHGRI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2011
• First Posted: March 16, 2011
• Study Start: May 6, 2011
• Last Updated: June 5, 2026

Record last verified: 2026-04-17

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Within 3 months after the last data generated.
• Access Criteria: Data will be shared through dbGaP with controlled access based on IRB approval: requestor must provide documentation of local IRB approval.

Locations

US (1)