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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01316783
First received: March 15, 2011
Last updated: August 15, 2014
Last verified: July 2014
  Purpose

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
Diabetes
Cardiovascular Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Genetics of Obesity, Diabetes, and Heart Disease in African Diaspora Populations

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 1000
Study Start Date: March 2011
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) 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01316783

Contacts
Contact: Shirley Freeman (301) 451-2302 freemansh@mail.nih.gov
Contact: Charles N Rotimi, M.D. (301) 451-2303 rotimic@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Charles N Rotimi, M.D. National Human Genome Research Institute (NHGRI)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT01316783     History of Changes
Other Study ID Numbers: 110110, 11-HG-0110
Study First Received: March 15, 2011
Last Updated: August 15, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Africans
Obesity
Diabetes
Heart Disease
Genetic
African Descent
Cardiovascular Disease

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Nutrition Disorders
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Obesity
Diabetes Mellitus
Overnutrition
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014