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Admixture Mapping of Ethnic and Racial Insulin Complex Outcomes (AMERICO)

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ClinicalTrials.gov Identifier: NCT00726778
Recruitment Status : Completed
First Posted : August 1, 2008
Last Update Posted : March 16, 2011
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:
University of Alabama at Birmingham

Brief Summary:
The main objective of this study is to investigate the effect of genetic and environmental parameters on racial/ethnic differences in aspects of insulin secretion and action. The genetic component will be modeled by estimating the degree of European genetic admixture (ADM) obtained from approximately 50 ancestry informative markers (AIMs). The environmental components will be modeled by measuring energy intake (food intake), energy expenditure (physical activity) and socioeconomic status.

Condition or disease

Study Type : Observational
Estimated Enrollment : 360 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Admixture Mapping of Ethnic and Racial Insulin Complex Outcomes
Study Start Date : May 2004
Primary Completion Date : December 2008
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin
U.S. FDA Resources

A, Observational
Healthy European American, African American, and Hispanic American children aged 7-12

Primary Outcome Measures :
  1. To test the role of European genetic admixture on measures of insulin action and response in a multiethnic group of prepubertal children. [ Time Frame: 5 years ]
  2. To investigate whether the impact of energy intake, energy expenditure and socioeconomic status on proxy measures of insulin sensitivity and/or action differ as a function of European ADM in prepubertal children [ Time Frame: 5 years ]
  3. To test phenotype-genotype associations between each one of the AIMs and measures of FI, SI and AIRg after adjusting for body composition in a sample of AA, HA and EA prepubertal children. [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA
Three 5-ml blood samples will be obtained from each subject and sent to the Laboratory Core of the General Clinical Research Center to establish EBV lymphoblastoid cell lines and for DNA extraction. EBV lines will be kept at UAB for future genetic analysis. Extracted DNA will be sent to Dr. Mark Shriver at the Pennsylvania State University for genotyping of the ancestry informative markers (AIMs).

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
120 African Americans, 120 European Americans and 120 Hispanic Americans (60 males and 60 females per group). To minimize the influence of puberty on SI and AIRg, recruitment will be limited to individuals between ages 7-12, a range that based on previous observations from our team, categorize children from Tanner stage 1 and 2.

Inclusion Criteria:

  • African American, European American, or Hispanic American, aged 7-12, healthy, weight is equal to or greater than 25 Kg

Exclusion Criteria:

  • Type 1 or 2 diabetes, polycystic ovary disease, disturbances in glucose or lipid metabolism disturbances
  • Use of medication known to affect body composition or physical activity, diagnosis of genetic disorders known to affect body composition or fat distribution
  • Use of tobacco, alcohol consumption in excess of 400 g per week
  • Menstruated for more than a year prior to the recruitment; OR
  • A medical history that counter-indicates inclusion of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00726778

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Jose Fernandez, Ph.D. UA B

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jose Fernandez, UAB
ClinicalTrials.gov Identifier: NCT00726778     History of Changes
Other Study ID Numbers: F040109007
R01DK067426 ( U.S. NIH Grant/Contract )
First Posted: August 1, 2008    Key Record Dates
Last Update Posted: March 16, 2011
Last Verified: March 2011

Keywords provided by University of Alabama at Birmingham:
insulin senistivity
genetic admixture
type 2 diabetes
body composition
Insulin dynamics
Racial/ethnic differences

Additional relevant MeSH terms:
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs