ObesityNCT00484172
Genomic Search for Childhood Obesity Genes-A Pilot Study
An observational study of Obesity, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
The purpose of this study is to screen a pediatric population (ages 2-8) for genes associated with childhood obesity. Read more about this study
- Who is it for?
- Ages 2 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- blood draws
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jun 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 2 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged 2-8 years old
Who may be able to join
- Ages 2-8, predominately Caucasian to minimize population stratification
Who cannot join
- Chronic diseases (diabetes, cancer, etc) and known syndromes
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
The purpose of this study is to screen a pediatric population (ages 2-8) for genes associated with childhood obesity.
Read the detailed description
The incidence of childhood obesity has been growing at an epidemic rate for the past several years, in part due to the lack of understanding of mechanisms at a molecular level. This study will screen a healthy general pediatric population age 2 to 8 for potential genes associated with childhood obesity using whole genomic gene arrays. Patients with BMI values equal to or greater than the 85th percentile will be compared to patients with a BMI below or equal to the 15th percentile. The INSIG2 gene will be specifically studied because of its identification in several populations of obese subjects. The differences in gene expression of the 2 groups will then be used to identify new genes for investigation in childhood obesity.
- Conditions
- Obesity
- Being tested
- blood draws
- Keywords
- Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood drawsProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionJun 2008
- Study completionJun 2008
Why it stopped: Study Withdrawn due to Investigator leaving
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Merlin G Butler, M.D., Ph.D., Principal investigator, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00484172
- Sponsor's protocol ID
- 07 03-045E
- Status last verified
- Jan 2021
- First submitted
- 7 Jun 2007
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomic Search for Childhood Obesity Genes-A Pilot Study
- ClinicalTrials.gov ID
- NCT00484172
- Acronym / sponsor ID
- 07 03-045E
- Conditions
- Obesity
- Keywords
- Obesity
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study Withdrawn due to Investigator leaving
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- Jun 2007 (actual)
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 8 Jun 2007 (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.
The purpose of this study is to screen a pediatric population (ages 2-8) for genes associated with childhood obesity.
Detailed description
The incidence of childhood obesity has been growing at an epidemic rate for the past several years, in part due to the lack of understanding of mechanisms at a molecular level. This study will screen a healthy general pediatric population age 2 to 8 for potential genes associated with childhood obesity using whole genomic gene arrays. Patients with BMI values equal to or greater than the 85th percentile will be compared to patients with a BMI below or equal to the 15th percentile. The INSIG2 gene will be specifically studied because of its identification in several populations of obese subjects. The differences in gene expression of the 2 groups will then be used to identify new genes for investigation in childhood obesity.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged 2-8 years old
Key inclusion criteria (1 listed)
- Ages 2-8, predominately Caucasian to minimize population stratification
Key exclusion criteria (1 listed)
- Chronic diseases (diabetes, cancer, etc) and known syndromes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood draws | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
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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.
Merlin G Butler, M.D., Ph.D. principal investigator
Children's Mercy Hospital Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Children's Mercy Hospital Kansas City at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 withdrawn before enrolling participants, so there are no results.
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.
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 6 Jan 2021.