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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01770054
Other study ID # TAP 001-2013
Secondary ID 001-2013-01
Status Completed
Phase N/A
First received January 15, 2013
Last updated March 7, 2013
Start date January 2013
Est. completion date March 2013

Study information

Verified date March 2013
Source Hospital Clínica Kennedy
Contact n/a
Is FDA regulated No
Health authority Ecuador: Ethical Committee
Study type Observational [Patient Registry]

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 517
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years and older
Eligibility Inclusion Criteria:

- Atahualpa resident aged 40 years or more

Exclusion Criteria:

- non-consenting persons

Study Design

Observational Model: Ecologic or Community, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Intervention

Other:
obtention of a blood sample
a blood sample will be obtained to measure glucose, HDL cholesterol, triglycerides, and for genetic testing

Locations

Country Name City State
Ecuador Center of Health Atahualpa Santa Elena

Sponsors (1)

Lead Sponsor Collaborator
Hospital Clínica Kennedy

Country where clinical trial is conducted

Ecuador, 

Outcome

Type Measure Description Time frame Safety issue
Other determination of the prevalence of hyperinsulinemia plasma insulin levels will be determined 5 months No
Primary Prevalence of metabolic syndrome determination of the metabolic syndrome in subjects aged 40 years or more 5 months No
Secondary 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 5 months No
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