Genetic Epidemiology and Energy Metabolism in Black Girls

Obesity Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00014872
• Other study ID #: 968
• Secondary ID: R01HL066070
• Status: Terminated
• Start date: April 2008
• Est. completion date: April 2008

Study information

• Verified date: December 2023
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To investigate the role of genes and energy metabolism in the pathogenesis of obesity in adolescent Black girls.

Description:

BACKGROUND:

The high prevalence of obesity in African-American (AA) women is of public health importance since AA women suffer higher mortality from cardiovascular and renal diseases than do white women. The reason for their marked susceptibility to obesity remains poorly understood though it is now known that AA women manifest lower resting energy expenditure than white women.

DESIGN NARRATIVE:

This is a multi-pronged metabolic and genetic epidemiologic study to examine two candidate genes (UCP3 and b3AR) implicated in energy metabolism. A total of 600 African American girls, aged 12-15 years, will be screened using buccal swabs as a non-invasive method of obtaining DNA, to determine their UCP3 genotypes as well as b3AR genotypes. An estimated 211 girls will be recruited, selected based on their UCP3 genotype, for measurements of resting energy expenditure and body composition (using dual energy X-ray absorptiometry [DEXA]) in a controlled setting of the Clinical Research Center at the Cincinnati Children's Hospital. Variation in resting energy expenditure will be examined across the genotypes of UCP3 with a large sample. The 2x3 design will allow the investigators to examine whether the effects associated with UCP3 variation are due to the UCP3 locus alone or due to the additive effect or interaction between UCP3 and b3AR. The study will help to elucidate the relationship between variation in two important candidate genes for energy metabolism, UCP3 and b3AR, and inter-individual variation in the levels of resting energy expenditure in this very high risk (for obesity) population.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 600
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 12 Years to 15 Years
• Eligibility: No eligibility criteria

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Obesity

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of New Mexico	National Heart, Lung, and Blood Institute (NHLBI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	UCP3 genotype correlation to obesity		six months