DiabetesNCT01316783
Genetics of Obesity, Diabetes, and Heart Disease in African Diaspora Populations
An observational study of Diabetes and Cardiovascular Disease, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Cardiovascular Disease
- How many people
- 1,100 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2011to not given
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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. This study only includes adults because these phenotypes are more commonly present in adults. In summary, inclusion criteria include:
- 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
Who cannot join
- Related individuals are excluded to avoid biases in our analyses due to genomic similarities between people who are related. Adults unable to consent will be included in this study. Pregnant women are excluded from this study because pregnancy induces changes in metabolism that would interfere with the measurements and outcomes of the study. In summary, exclusion criteria include:
- Individuals related to participants (any known familial relationship, as reported by the prospective enrollee)
- Adults unable to consent
- Pregnant women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the detailed description
Study Description:
The study is to perform a quantitative trait analysis of multiple metabolic biomarkers and disorders including T2D, hypertension, CVD and obesity in a total of 1000 people of African ancestry and approximately 100 whites (who will serve as a comparison group) residing in the United States.
We will also perform exome sequencing of 48 cases of African descent and genotype identified variants in the larger cohort. Cases for exome sequencing will consist of individuals who have more than one metabolic condition, i.e., diabetes, pre-diabetes, obesity, hypertension and/or dyslipidemia. We propose to carry out exome capture of 48 individuals (96 chromosomes).
Objectives:
Primary Objective: Genotype variants of interest from genetic epidemiology studies conducted in Dr. Rotimi's lab in these individuals, with thorough clinical measurements available, in order to investigate biological mechanisms underlying observed associations.
Secondary Objectives: Conduct whole-exome capture on a subset of cases with at least 2 metabolic disorders (i.e., diabetes, pre-diabetes, obesity, hypertension and/or dyslipidemia). Genotype identified variants in the larger cohort of 1000 persons or in existing studies of African ancestry individuals (Howard University Family Study or Africa America Diabetes Mellitus Study).
- Conditions
- Diabetes, Cardiovascular Disease
- Keywords
- Cardiometabolic Diseases, Natural History
- Medical subject headings
- Diabetes Mellitus, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | African ancestry and whites (who will serve as a comparison group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic disorders
type 2 diabetes, metabolic outcomes, dyslipidemia
Measured: One study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2011 (estimated)
- Study start6 May 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Charles N Rotimi, M.D., Principal investigator, National Human Genome Research Institute (NHGRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01316783
- Sponsor's protocol ID
- 110110
- Other IDs
- 11-HG-0110
- Status last verified
- 8 Sep 2026
- First submitted
- 15 Mar 2011
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD will be shared through dbGAP following completion of data collection and planned assays.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetics of Obesity, Diabetes, and Heart Disease in African Diaspora Populations
- ClinicalTrials.gov ID
- NCT01316783
- Acronym / sponsor ID
- 110110
- Conditions
- Diabetes, Cardiovascular Disease
- Keywords
- Cardiometabolic Diseases, Natural History
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- 6 May 2011 (actual)
- First posted
- 16 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Description:
The study is to perform a quantitative trait analysis of multiple metabolic biomarkers and disorders including T2D, hypertension, CVD and obesity in a total of 1000 people of African ancestry and approximately 100 whites (who will serve as a comparison group) residing in the United States.
We will also perform exome sequencing of 48 cases of African descent and genotype identified variants in the larger cohort. Cases for exome sequencing will consist of individuals who have more than one metabolic condition, i.e., diabetes, pre-diabetes, obesity, hypertension and/or dyslipidemia. We propose to carry out exome capture of 48 individuals (96 chromosomes).
Objectives:
Primary Objective: Genotype variants of interest from genetic epidemiology studies conducted in Dr. Rotimi's lab in these individuals, with thorough clinical measurements available, in order to investigate biological mechanisms underlying observed associations.
Secondary Objectives: Conduct whole-exome capture on a subset of cases with at least 2 metabolic disorders (i.e., diabetes, pre-diabetes, obesity, hypertension and/or dyslipidemia). Genotype identified variants in the larger cohort of 1000 persons or in existing studies of African ancestry individuals (Howard University Family Study or Africa America Diabetes Mellitus Study).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | –African ancestry and whites (who will serve as a comparison group) |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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. This study only includes adults because these phenotypes are more commonly present in adults. In summary, inclusion criteria include:
- Persons who self-identify as either
- Persons >= 18 years
- Participation in a protocol with Dr. Anne Sumner, NIDDK
Key exclusion criteria (4 listed)
- Related individuals are excluded to avoid biases in our analyses due to genomic similarities between people who are related. Adults unable to consent will be included in this study. Pregnant women are excluded from this study because pregnancy induces changes in metabolism that would interfere with the measurements and outcomes of the study. In summary, exclusion criteria include:
- Individuals related to participants (any known familial relationship, as reported by the prospective enrollee)
- Adults unable to consent
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Metabolic disorders
Time frame: One study visit
type 2 diabetes, metabolic outcomes, dyslipidemia
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All collected IPD will be shared through dbGAP following completion of data collection and planned assays.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charles N Rotimi, M.D. principal investigator
National Human Genome Research Institute (NHGRI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Cardiovascular Disease, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic disorders (time frame: One study visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.