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Prevalence of Metabolic Syndrome in Atahualpa

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ClinicalTrials.gov Identifier: NCT01770054
Recruitment Status : Completed
First Posted : January 17, 2013
Last Update Posted : March 8, 2013
Sponsor:
Information provided by (Responsible Party):
Oscar H. Del Brutto, MD, Hospital Clínica Kennedy

Brief 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.

Condition or disease Intervention/treatment
Metabolic Syndrome Other: obtention of a blood sample

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 [Patient Registry]
Actual Enrollment : 517 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 2 Months
Official Title: Evaluation of the Prevalence of Metabolic Syndrome in Atahualpa Residents Aged 40 Years or More.
Study Start Date : January 2013
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

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U.S. FDA Resources

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



Primary Outcome Measures :
  1. Prevalence of metabolic syndrome [ Time Frame: 5 months ]
    determination of the metabolic syndrome in subjects aged 40 years or more


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. determination of the prevalence of hyperinsulinemia [ Time Frame: 5 months ]
    plasma insulin levels will be determined


Biospecimen Retention:   Samples With DNA
Blood


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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
all Atahualpa residents aged 40 years or more
Criteria

Inclusion Criteria:

  • Atahualpa resident aged 40 years or more

Exclusion Criteria:

  • non-consenting persons

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01770054


Locations
Ecuador
Center of Health
Atahualpa, Santa Elena, Ecuador, 0000
Sponsors and Collaborators
Hospital Clínica Kennedy
Investigators
Principal Investigator: Oscar H Del Brutto, MD Universidad de Especialidades del Espíritu Santo

Responsible Party: Oscar H. Del Brutto, MD, Rsearch Proffesor, Universidad de Especialidades Espiritu Santo, Hospital Clínica Kennedy
ClinicalTrials.gov Identifier: NCT01770054     History of Changes
Other Study ID Numbers: TAP 001-2013
001-2013-01 ( Other Grant/Funding Number: Universidad de Especialidades Espiritu Santo )
First Posted: January 17, 2013    Key Record Dates
Last Update Posted: March 8, 2013
Last Verified: March 2013

Keywords provided by Oscar H. Del Brutto, MD, Hospital Clínica Kennedy:
metabolic syndrome
diabetes mellitus

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases