OBESITYNCT01750333
Study on Correlation Between Vascular ET-1 and Adiponectin in Pediatric Obesity
An observational study of OBESITY and Endothelial Dysfunction, run by Monica Montagnani at 1 site in Italy.
Trial summary
The aim of this study is to explore whether and how high circulating levels of endothelin-1 (ET-1) in obese and overweight children may contribute to impair adiponectin (Ad) production, release and vascular activity Read more about this study
- Who is it for?
- Ages 5 to 13 years
- Conditions the study is for
- OBESITY, Endothelial Dysfunction, Insulin Resistance
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2012to Mar 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 5 to 13 years
- All sexes
- No healthy volunteers
- Child
Study population: CHILDREN ATTENDING THE OUTPATIENT UNIT OF THE UNIVERSITY PEDIATRIC CLINIC
Who may be able to join
- Children will be enrolled into lean, overweight or obese groups based on Body mass index (BMI) calculated according to standard methods. International standards for sex-and age-specific BMI centiles for subjects aged 2-18 years will be used. The 95th centile of BMI reference is the cut off point for childhood obesity. Overweight and obese children are defined as those with a BMI higher than the centile curves.
Who cannot join
- presence of renal, liver and/or cardiovascular diseases;
- hypertension;
- metabolic and/or endocrine disorders;
- genetic syndromes;
- histories of chronic allergies, acute infectious or inflammatory diseases during the last 3 months preceding the study
Trial locations and contacts
1 site in 1 country.
Italy1 site
University of Bari Medical School - Dept Biomedical Sciences and Human Oncology
Bari, 70124
About this study
Official title: Observational Retrospective Study on Correlation Between ET-1 and Ad in Obese Children
The aim of this study is to explore whether and how high circulating levels of endothelin-1 (ET-1) in obese and overweight children may contribute to impair adiponectin (Ad) production, release and vascular activity
- Conditions
- OBESITY, Endothelial Dysfunction, Insulin Resistance
- Medical subject headings
- Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lean children | Not described | |
| Overweight Children (OW) | Not described | |
| Obese children (Ob) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between serum levels of ET-1 and Ad in lean, overweight and obese children
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startApr 2012
- Primary completionMar 2013 (estimated)
- Study completionMar 2013 (estimated)
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
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Monica Montagnani
- Responsible party
- Sponsor-investigator, Monica Montagnani, Montagnani, Monica, M.D., Ph.D.
- Investigators
- Monica Montagnani, MD, PhD, Principal investigator, University of Bari Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01750333
- Sponsor's protocol ID
- OBETAD-01
- Status last verified
- Dec 2012
- First submitted
- 12 Dec 2012
- Last updated
- 17 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Retrospective Study on Correlation Between ET-1 and Ad in Obese Children
- ClinicalTrials.gov ID
- NCT01750333
- Acronym / sponsor ID
- OBETAD-01
- Conditions
- OBESITY, Endothelial Dysfunction, Insulin Resistance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Monica Montagnani
- Study start
- Apr 2012
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 17 Dec 2012 (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 aim of this study is to explore whether and how high circulating levels of endothelin-1 (ET-1) in obese and overweight children may contribute to impair adiponectin (Ad) production, release and vascular activity
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lean children | – | – |
| Overweight Children (OW) | – | – |
| Obese children (Ob) | – | – |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- CHILDREN ATTENDING THE OUTPATIENT UNIT OF THE UNIVERSITY PEDIATRIC CLINIC
Key inclusion criteria (1 listed)
- Children will be enrolled into lean, overweight or obese groups based on Body mass index (BMI) calculated according to standard methods. International standards for sex-and age-specific BMI centiles for subjects aged 2-18 years will be used. The 95th centile of BMI reference is the cut off point for childhood obesity. Overweight and obese children are defined as those with a BMI higher than the centile curves.
Key exclusion criteria (5 listed)
- presence of renal, liver and/or cardiovascular diseases;
- hypertension;
- metabolic and/or endocrine disorders;
- genetic syndromes;
- histories of chronic allergies, acute infectious or inflammatory diseases during the last 3 months preceding the study
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 between serum levels of ET-1 and Ad in lean, overweight and obese children
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2012.
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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.
Monica Montagnani, MD, PhD principal investigator
University of Bari Medical School
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 Endothelial Dysfunction, run by Monica Montagnani at 1 site in Italy.
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 5 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: status not confirmed, as of the sponsor's last update on 17 Dec 2012. 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 Italy. 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?
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 between serum levels of ET-1 and Ad in lean, overweight and obese children (time frame: 12 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 17 Dec 2012.