Metabolic SyndromeNCT01770054
Prevalence of Metabolic Syndrome in Atahualpa
An observational study of Metabolic Syndrome, run by Hospital Clínica Kennedy at 1 site in Ecuador.
Trial summary
A recent epidemiologic survey demonstrated a high prevalence of type 2 diabetes mellitus in Atahualpa residents. Now, the investigators attempt to evaluate the prevalence of the metabolic syndrome in adults aged 40 years or more living in this rural village of coastal Ecuador. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- obtention of a blood sample
- How many people
- 517 participants
- Where
- 1 siteEcuador
- Study dates
- Jan 2013to Mar 2013
- How long will I take part?
- 2 Months
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: all Atahualpa residents aged 40 years or more
Who may be able to join
- Atahualpa resident aged 40 years or more
Who cannot join
- non-consenting persons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Prevalence of Metabolic Syndrome in Atahualpa Residents Aged 40 Years or More.
A recent epidemiologic survey demonstrated a high prevalence of type 2 diabetes mellitus in Atahualpa residents. Now, the investigators attempt to evaluate the prevalence of the metabolic syndrome in adults aged 40 years or more living in this rural village of coastal Ecuador.
Read the detailed description
Several studies have shown that the occurrence of the metabolic syndrome is a risk factor for the development of cerebrovascular and ischemic heart disease. To evaluate the prevalence of the metabolic syndrome, we will invite all Atahualpa residents aged 40 years or more to participate in this study. For the purposes of this study we will obtain the waist circumference of all individuals, will measure their blood pressure using a standard protocol, and will take a blood sample to determine fasting glucose levels, HDL cholesterol levels, triglyceride levels, and plasma insulin levels.
- Conditions
- Metabolic Syndrome
- Being tested
- obtention of a blood sample
- Keywords
- metabolic syndrome, diabetes mellitus
- Medical subject headings
- Metabolic Syndrome, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
obtention of a blood sampleOther
a blood sample will be obtained to measure glucose, HDL cholesterol, triglycerides, and for genetic testing
| Study group | Role | What they receive |
|---|---|---|
| obtention of a blood sample | all Atahualpa residents aged 40 years or more Receives: Other: obtention of a blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of metabolic syndrome
determination of the metabolic syndrome in subjects aged 40 years or more
Measured: 5 months
Secondary outcomes (1)
Genetic testing
Blood will be taken to evaluate the ADN pattern of this population, to compare with other Amerindian populations with a proven high prevalence of diabetes mellitus and metabolic syndrome
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 517 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Hospital Clínica Kennedy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oscar H. Del Brutto, MD, Hospital Clínica Kennedy
- Investigators
- Oscar H Del Brutto, MD, Principal investigator, Universidad de Especialidades Espiritu Santo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01770054
- Sponsor's protocol ID
- TAP 001-2013
- Other IDs
- 001-2013-01
- Status last verified
- Mar 2013
- First submitted
- 15 Jan 2013
- Last updated
- 8 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Prevalence of Metabolic Syndrome in Atahualpa Residents Aged 40 Years or More.
- ClinicalTrials.gov ID
- NCT01770054
- Acronym / sponsor ID
- TAP 001-2013
- Conditions
- Metabolic Syndrome
- Keywords
- metabolic syndrome, diabetes mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 517 participants (actual)
- Lead sponsor
- Hospital Clínica KennedyUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 17 Jan 2013 (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.
A recent epidemiologic survey demonstrated a high prevalence of type 2 diabetes mellitus in Atahualpa residents. Now, the investigators attempt to evaluate the prevalence of the metabolic syndrome in adults aged 40 years or more living in this rural village of coastal Ecuador.
Detailed description
Several studies have shown that the occurrence of the metabolic syndrome is a risk factor for the development of cerebrovascular and ischemic heart disease. To evaluate the prevalence of the metabolic syndrome, we will invite all Atahualpa residents aged 40 years or more to participate in this study. For the purposes of this study we will obtain the waist circumference of all individuals, will measure their blood pressure using a standard protocol, and will take a blood sample to determine fasting glucose levels, HDL cholesterol levels, triglyceride levels, and plasma insulin levels.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| obtention of a blood sample | – | Other: obtention of a blood sampleall Atahualpa residents aged 40 years or more |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- all Atahualpa residents aged 40 years or more
Key inclusion criteria (1 listed)
- Atahualpa resident aged 40 years or more
Key exclusion criteria (1 listed)
- non-consenting persons
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 |
|---|---|---|
| obtention of a blood samplea blood sample will be obtained to measure glucose, HDL cholesterol, triglycerides, and for genetic testing | Other | obtention of a blood sample |
Primary outcome
Prevalence of metabolic syndrome
Time frame: 5 months
determination of the metabolic syndrome in subjects aged 40 years or more
1 secondary outcome
Genetic testing
Time frame: 5 months
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 8 Mar 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.
Oscar H Del Brutto, MD principal investigator
Universidad de Especialidades Espiritu Santo
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, run by Hospital Clínica Kennedy at 1 site in Ecuador.
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 8 Mar 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 Ecuador. 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?
Prevalence of metabolic syndrome (time frame: 5 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 8 Mar 2013.