Cardiovascular DiseasesNCT00014872
Genetic Epidemiology and Energy Metabolism in Black Girls
An observational study of Cardiovascular Diseases and Obesity, run by University of New Mexico.
Trial summary
To investigate the role of genes and energy metabolism in the pathogenesis of obesity in adolescent Black girls. Read more about this study
- Who is it for?
- Ages 12 to 15 years, women only
- Conditions the study is for
- Cardiovascular Diseases, Obesity
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Apr 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 15 years
- Women only
- No healthy volunteers
- Child
Study population: 12-15 years old black girl with Cardiovascular Diseases Obesity
No eligibility criteria
About this study
To investigate the role of genes and energy metabolism in the pathogenesis of obesity in adolescent Black girls.
Read the detailed 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.
- Conditions
- Cardiovascular Diseases, Obesity
- Medical subject headings
- Cardiovascular Diseases, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
UCP3 genotype correlation to obesity
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2001 (estimated)
- Study startApr 2008
- Primary completionApr 2008
- Study completionApr 2008
Why it stopped: This is not a clinical trial and was inadvertently entered into CT.gov
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Sue Kimm, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00014872
- Sponsor's protocol ID
- 968
- Other IDs
- R01HL066070
- Status last verified
- Dec 2023
- First submitted
- 11 Apr 2001
- Last updated
- 14 Dec 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Epidemiology and Energy Metabolism in Black Girls
- ClinicalTrials.gov ID
- NCT00014872
- Acronym / sponsor ID
- 968
- Conditions
- Cardiovascular Diseases, Obesity
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: This is not a clinical trial and was inadvertently entered into CT.gov
- Enrolment
- 600 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Apr 2008 (actual)
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 12 Apr 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the role of genes and energy metabolism in the pathogenesis of obesity in adolescent Black girls.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 15 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 12-15 years old black girl with Cardiovascular Diseases Obesity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
UCP3 genotype correlation to obesity
Time frame: six months
Results and safety
The study was stopped early (reason given: This is not a clinical trial and was inadvertently entered into CT.gov). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sue Kimm principal investigator
University of New Mexico
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Obesity, run by University of New Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: This is not a clinical trial and was inadvertently entered into CT.gov). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UCP3 genotype correlation to obesity (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2023.