NCT00726778

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

March 16, 2011

Status Verified

March 1, 2011

Enrollment Period

4.6 years

First QC Date

July 29, 2008

Last Update Submit

March 15, 2011

Conditions

Healthy

Keywords

race/ethnicityinsulin senistivitygenetic admixturetype 2 diabetesobesitybody compositionInsulin dynamicsRacial/ethnic differences

Outcome Measures

Primary Outcomes (3)

  • To test the role of European genetic admixture on measures of insulin action and response in a multiethnic group of prepubertal children.

    5 years

  • 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

    5 years

  • 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.

    5 years

Study Arms (1)

A, Observational

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

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (2)

  • Cardel M, Lemas DJ, Jackson KH, Friedman JE, Fernandez JR. Higher Intake of PUFAs Is Associated with Lower Total and Visceral Adiposity and Higher Lean Mass in a Racially Diverse Sample of Children. J Nutr. 2015 Sep;145(9):2146-52. doi: 10.3945/jn.115.212365. Epub 2015 Aug 12.

    PMID: 26269238DERIVED

  • Kell KP, Cardel MI, Bohan Brown MM, Fernandez JR. Added sugars in the diet are positively associated with diastolic blood pressure and triglycerides in children. Am J Clin Nutr. 2014 Jul;100(1):46-52. doi: 10.3945/ajcn.113.076505. Epub 2014 Apr 9.

    PMID: 24717340DERIVED

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).

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Obesity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jose Fernandez, Ph.D.

    UA B

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 29, 2008

First Posted

August 1, 2008

Study Start

May 1, 2004

Primary Completion

December 1, 2008

Study Completion

December 1, 2010

Last Updated

March 16, 2011

Record last verified: 2011-03

Locations

US(1)