ObesityNCT00436488
Frequency of ICAM-1 Polymorphisms in Obese Subjects
An observational study of Obesity, run by Istituto Auxologico Italiano.
Trial summary
The genetic contribution to the development of obesity is now well recognized. However obesity is a polygenic disease and thus many genes are likely to be involved. This study aims to investigate the possible association between specific variants of the gene coding for the Intercellular Adhesion Molecule-1 (ICAM-1)and… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Jul 2006
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Obesity
Who cannot join
- Associated inflammatory diseases
About this study
Official title: Study of the Association Between ICAM-1 Polymorphisms and Severe Obesity
The genetic contribution to the development of obesity is now well recognized. However obesity is a polygenic disease and thus many genes are likely to be involved. This study aims to investigate the possible association between specific variants of the gene coding for the Intercellular Adhesion Molecule-1 (ICAM-1)and the development of severe obesity in an Italian population
Read the detailed description
Severely obese subjects referred to our institution will be evaluated. For the aim of the study, a venous blood sample will be obtained from these subjects and from a group of normal weight volunteers. Genomic DNA will be extracted from the blood samples and analysed by standard molecular biology techniques.The allelic and genotype frequencies of the two ICAM-1 variants will be calculated in the obese and control groups. The statistical significance of possible differences will be determined
- Conditions
- Obesity
- Keywords
- ICAM-1, Obesity, Gene variants
- Medical subject headings
- Obesity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2007 (estimated)
- Study startJan 2005
- Study completionJul 2006
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.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- 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
- Defined population
- Time perspective
- Prospective
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Investigators
- Anna Maria Di Blasio, MD, Principal investigator, Istituto Auxologico Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00436488
- Sponsor's protocol ID
- 12C501
- Status last verified
- Feb 2007
- First submitted
- 16 Feb 2007
- Last updated
- 19 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Association Between ICAM-1 Polymorphisms and Severe Obesity
- ClinicalTrials.gov ID
- NCT00436488
- Acronym / sponsor ID
- 12C501
- Conditions
- Obesity
- Keywords
- ICAM-1, Obesity, Gene variants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- Jan 2005
- Study completion
- Jul 2006
- First posted
- 19 Feb 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 genetic contribution to the development of obesity is now well recognized. However obesity is a polygenic disease and thus many genes are likely to be involved. This study aims to investigate the possible association between specific variants of the gene coding for the Intercellular Adhesion Molecule-1 (ICAM-1)and the development of severe obesity in an Italian population
Detailed description
Severely obese subjects referred to our institution will be evaluated. For the aim of the study, a venous blood sample will be obtained from these subjects and from a group of normal weight volunteers. Genomic DNA will be extracted from the blood samples and analysed by standard molecular biology techniques.The allelic and genotype frequencies of the two ICAM-1 variants will be calculated in the obese and control groups. The statistical significance of possible differences will be determined
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Obesity
Key exclusion criteria (1 listed)
- Associated inflammatory diseases
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2007.
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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.
Anna Maria Di Blasio, MD principal investigator
Istituto Auxologico Italiano
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Istituto Auxologico Italiano.
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: finished, as of the sponsor's last update on 19 Feb 2007. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 19 Feb 2007.