Clinical trial NCT00726778: Admixture Mapping of Ethnic and Racial Insulin Complex Outcomes
Official title: Admixture Mapping of Ethnic and Racial Insulin Complex Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: race/ethnicity
insulin senistivity
genetic admixture
type 2 diabetes
obesity
body composition
Insulin dynamics
Racial/ethnic differences
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2008-08-01
Enrollment: 360
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility 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

Primary outcomes:
measure: To test the role of European genetic admixture on measures of insulin action and response in a multiethnic group of prepubertal children.
timeFrame: 5 years
measure: 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
timeFrame: 5 years
measure: 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.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: UA B
name: Jose Fernandez, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.