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OpenTrials
Completed

NCT Number: NCT00726778

Admixture Mapping of Ethnic and Racial Insulin Complex Outcomes

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.

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Key information

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: AMERICO

Important dates

Study start
2004
Primary completion
2008
Study completion
2010
First posted
Aug 1, 2008
Registry last updated
Mar 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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