Metabolic Syndrome XNCT00864461
Frequency of Metabolic Syndrome in Down Syndrome Patients
An observational study of Metabolic Syndrome X and Down Syndrome, run by Universidad de Guanajuato at 1 site in Mexico.
Trial summary
The aim of this study is to assess the frequency of metabolic syndrome in Down syndrome patients because the prevalence of diabetes mellitus and obesity is higher in individuals with Down syndrome than in the general population. Read more about this study
- Who is it for?
- Ages 7 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome X, Down Syndrome
- How many people
- 96 participants
- Where
- 1 siteMexico
- Study dates
- 1 Sep 2009to 31 Mar 2010
- 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 7 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Community sample
Who may be able to join
- Clinical diagnosis of Down syndrome
Who cannot join
- History of congenital cardiac defects requiring open-heart surgery
- History of gastroenterologic anomalies requiring bowel resection and/or ongoing medical intervention
- History of leukemia or other cancer
- History of hypothyroidism requiring thyroid hormone replacement
Trial locations and contacts
1 site in 1 country.
Mexico1 site
School of Medicine, University of Guanajuato
León, Guanajuato, 37320
About this study
Official title: Prevalence of Metabolic Syndrome in Down Syndrome Patients
The aim of this study is to assess the frequency of metabolic syndrome in Down syndrome patients because the prevalence of diabetes mellitus and obesity is higher in individuals with Down syndrome than in the general population.
- Conditions
- Metabolic Syndrome X, Down Syndrome
- Keywords
- Down syndrome, Metabolic syndrome X, Insulin resistance
- Medical subject headings
- Metabolic Syndrome, Down Syndrome, 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 |
|---|---|---|
| Case | Patients with clinical and cytogenetics diagnosis of Down syndrome, between 7 - 24 years old. | |
| Control | Siblings of the same gender of the case, between 7-24 years old. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To asses the frequency of the metabolic syndrome among Down syndrome patients. Metabolic syndrome was defined by Adult Treatment Panel III criteria modified by Halley-Castillo.
Measured: One year
Secondary outcomes (1)
Evaluate the insulin resistance and insulin sensitivity using the HOMA and QUICKY methods.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2009 (estimated)
- Study start1 Sep 2009
- Primary completion21 Dec 2009
- Study completion31 Mar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Syndrome XStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Guanajuato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ALEJANDRO ERNESTO MACIAS HERNANDEZ, Universidad de Guanajuato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00864461
- Sponsor's protocol ID
- 249-08
- Status last verified
- May 2017
- First submitted
- 17 Mar 2009
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Metabolic Syndrome in Down Syndrome Patients
- ClinicalTrials.gov ID
- NCT00864461
- Acronym / sponsor ID
- 249-08
- Conditions
- Metabolic Syndrome X, Down Syndrome
- Keywords
- Down syndrome, Metabolic syndrome X, Insulin resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Universidad de GuanajuatoUniversity, hospital or other
- Study start
- 1 Sep 2009 (actual)
- Primary completion
- 21 Dec 2009 (actual)
- Study completion
- 31 Mar 2010 (actual)
- First posted
- 18 Mar 2009 (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 assess the frequency of metabolic syndrome in Down syndrome patients because the prevalence of diabetes mellitus and obesity is higher in individuals with Down syndrome than in the general population.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | –Patients with clinical and cytogenetics diagnosis of Down syndrome, between 7 - 24 years old. |
| Control | – | –Siblings of the same gender of the case, between 7-24 years old. |
Who may qualify
- Ages
- 7 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Community sample
Key inclusion criteria (1 listed)
- Clinical diagnosis of Down syndrome
Key exclusion criteria (4 listed)
- History of congenital cardiac defects requiring open-heart surgery
- History of gastroenterologic anomalies requiring bowel resection and/or ongoing medical intervention
- History of leukemia or other cancer
- History of hypothyroidism requiring thyroid hormone replacement
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
To asses the frequency of the metabolic syndrome among Down syndrome patients. Metabolic syndrome was defined by Adult Treatment Panel III criteria modified by Halley-Castillo.
Time frame: One year
1 secondary outcome
Evaluate the insulin resistance and insulin sensitivity using the HOMA and QUICKY methods.
Time frame: One year
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 5 May 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Metabolic Syndrome X and Down Syndrome, run by Universidad de Guanajuato at 1 site in Mexico.
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 4 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 5 May 2017. 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 Mexico. 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 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.
What does the primary outcome measure?
To asses the frequency of the metabolic syndrome among Down syndrome patients. Metabolic syndrome was defined by Adult Treatment Panel III criteria modified by Halley-Castillo. (time frame: One year). 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 5 May 2017; AzTrials last refreshed its copy on 7 Nov 2026.