Prevalence of Metabolic Syndrome in Atahualpa

March 7, 2013 updated by: Oscar H. Del Brutto, MD, Hospital Clínica Kennedy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

517

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ecuador
    • Santa Elena
      • Atahualpa, Santa Elena, Ecuador, 0000
        • Center of Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

all Atahualpa residents aged 40 years or more

Description

Inclusion Criteria:

  • Atahualpa resident aged 40 years or more

Exclusion Criteria:

  • non-consenting persons

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
obtention of a blood sample
all Atahualpa residents aged 40 years or more
Other: obtention of a blood sample
a blood sample will be obtained to measure glucose, HDL cholesterol, triglycerides, and for genetic testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of metabolic syndrome
Time Frame: 5 months
determination of the metabolic syndrome in subjects aged 40 years or more
5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genetic testing
Time Frame: 5 months
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
determination of the prevalence of hyperinsulinemia
Time Frame: 5 months
plasma insulin levels will be determined
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clínica Kennedy

Investigators

  • Principal Investigator: Oscar H Del Brutto, MD, Universidad de Especialidades Espiritu Santo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

January 15, 2013

First Submitted That Met QC Criteria

January 16, 2013

First Posted (Estimate)

January 17, 2013

Study Record Updates

Last Update Posted (Estimate)

March 8, 2013

Last Update Submitted That Met QC Criteria

March 7, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAP 001-2013
  • 001-2013-01 (Other Grant/Funding Number: Universidad de Especialidades Espiritu Santo)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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