Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00726778
First received: July 29, 2008
Last updated: March 15, 2011
Last verified: March 2011
  Purpose

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
Healthy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Admixture Mapping of Ethnic and Racial Insulin Complex Outcomes

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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).


Estimated Enrollment: 360
Study Start Date: May 2004
Study Completion Date: December 2010
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
A, Observational
Healthy European American, African American, and Hispanic American children aged 7-12

  Eligibility

Ages Eligible for Study:   7 Years to 12 Years
Genders Eligible for Study:   Both
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.

Criteria

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
  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: NCT00726778

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Jose Fernandez, Ph.D. UA B
  More Information

No publications provided

Responsible Party: Jose Fernandez, UAB
ClinicalTrials.gov Identifier: NCT00726778     History of Changes
Other Study ID Numbers: F040109007, R01DK067426
Study First Received: July 29, 2008
Last Updated: March 15, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Insulin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014