Prevalence of Metabolic Syndrome in Atahualpa

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oscar H. Del Brutto, MD, Hospital Clínica Kennedy
ClinicalTrials.gov Identifier:
NCT01770054
First received: January 15, 2013
Last updated: March 7, 2013
Last verified: March 2013
  Purpose

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 Intervention
Metabolic Syndrome
Other: obtention of a blood sample

Study Type: Observational [Patient Registry]
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Hospital Clínica Kennedy:

Primary Outcome Measures:
  • Prevalence of metabolic syndrome [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    determination of the metabolic syndrome in subjects aged 40 years or more


Secondary Outcome Measures:
  • Genetic testing [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    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:
  • determination of the prevalence of hyperinsulinemia [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    plasma insulin levels will be determined


Biospecimen Retention:   Samples With DNA

Blood


Enrollment: 517
Study Start Date: January 2013
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Espiritu Santo
  More Information

No publications provided

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
Study First Received: January 15, 2013
Last Updated: March 7, 2013
Health Authority: Ecuador: Ethical Committee

Keywords provided by Hospital Clínica Kennedy:
metabolic syndrome
diabetes mellitus

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

ClinicalTrials.gov processed this record on October 22, 2014