ObesityNCT01465789
Noninvasive Biomarkers for Monitoring Cardiometabolic Risk in Children
An observational study of Obesity and Metabolic Syndrome, run by West Virginia School of Osteopathic Medicine at 1 site in United States.
Trial summary
The purpose of this study is to identify salivary biomarkers for monitoring cardiometabolic risk in children. The study hypothesis is that a combination of salivary biomarkers will predict the presence of risk factors including impaired fasting glucose, hypertension and dyslipidemia and will reflect changes in these… Read more about this study
- Who is it for?
- Ages 4 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Metabolic Syndrome
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Jun 2013
- 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 4 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children participating in the CARDIAC Boot Camp program at the Robert C. Byrd Clinic in Lewisburg WV
Who may be able to join
- Participating in the CARDIAC Boot Camp Program
- Between the ages of 4 and 17
- Parental permission
- Ability to provide assent
Who cannot join
- Inability to comply with saliva collection procedures
- Renal insufficiency or juvenile gout
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia School of Osteopathic Medicine
Lewisburg, West Virginia, 24901
About this study
The purpose of this study is to identify salivary biomarkers for monitoring cardiometabolic risk in children. The study hypothesis is that a combination of salivary biomarkers will predict the presence of risk factors including impaired fasting glucose, hypertension and dyslipidemia and will reflect changes in these risk factors over time.
- Conditions
- Obesity, Metabolic Syndrome
- Medical subject headings
- Obesity, Metabolic Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation (R values) of salivary biomarkers with blood pressure percentile and serum glucose, HDL, total cholesterol, triglyceride and insulin levels in children
Measured: Baseline
Predictive utility (C-statistic) of salivary biomarkers for development of metabolic syndrome during childhood and adolescence
Measured: final assessment at age 18 (up to 14 years depending on age of enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2011 (estimated)
- Study startJul 2011
- Primary completionMay 2013
- Study completionJun 2013
Why it stopped: Loss of participants to follow-up
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia School of Osteopathic Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristie Bridges, West Virginia School of Osteopathic Medicine
- Investigators
- Kristie G Bridges, PhD, Principal investigator, West Virginia School of Osteopathic MedicineJill Cochran, PhD, MSN, RN-C FNP, Principal investigator, West Virginia School of Osteopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01465789
- Sponsor's protocol ID
- BCS 102.2
- Status last verified
- Aug 2013
- First submitted
- 5 Jul 2011
- Last updated
- 7 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Biomarkers for Monitoring Cardiometabolic Risk in Children
- ClinicalTrials.gov ID
- NCT01465789
- Acronym / sponsor ID
- BCS 102.2
- Conditions
- Obesity, Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Loss of participants to follow-up
- Enrolment
- 33 participants (actual)
- Lead sponsor
- West Virginia School of Osteopathic MedicineUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 7 Nov 2011 (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 identify salivary biomarkers for monitoring cardiometabolic risk in children. The study hypothesis is that a combination of salivary biomarkers will predict the presence of risk factors including impaired fasting glucose, hypertension and dyslipidemia and will reflect changes in these risk factors over time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children participating in the CARDIAC Boot Camp program at the Robert C. Byrd Clinic in Lewisburg WV
Key inclusion criteria (4 listed)
- Participating in the CARDIAC Boot Camp Program
- Between the ages of 4 and 17
- Parental permission
- Ability to provide assent
Key exclusion criteria (2 listed)
- Inability to comply with saliva collection procedures
- Renal insufficiency or juvenile gout
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
Correlation (R values) of salivary biomarkers with blood pressure percentile and serum glucose, HDL, total cholesterol, triglyceride and insulin levels in children
Time frame: Baseline
Predictive utility (C-statistic) of salivary biomarkers for development of metabolic syndrome during childhood and adolescence
Time frame: final assessment at age 18 (up to 14 years depending on age of enrollment)
Results and safety
The study was stopped early (reason given: Loss of participants to follow-up). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
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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.
Kristie G Bridges, PhD principal investigator
West Virginia School of Osteopathic Medicine
Jill Cochran, PhD, MSN, RN-C FNP principal investigator
West Virginia School of Osteopathic Medicine
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 and Metabolic Syndrome, run by West Virginia School of Osteopathic Medicine 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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 7 Aug 2013. 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 stopped early (reason given: Loss of participants to follow-up). 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?
Correlation (R values) of salivary biomarkers with blood pressure percentile and serum glucose, HDL, total cholesterol, triglyceride and insulin levels in children (time frame: Baseline). The study lists 2 primary outcomes in all. 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 7 Aug 2013.