NCT01770054

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
517

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 17, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

March 8, 2013

Status Verified

March 1, 2013

Enrollment Period

2 months

First QC Date

January 15, 2013

Last Update Submit

March 7, 2013

Conditions

Metabolic Syndrome

Keywords

metabolic syndromediabetes mellitus

Outcome Measures

Primary Outcomes (1)

  • Prevalence of metabolic syndrome

    determination of the metabolic syndrome in subjects aged 40 years or more

    5 months

Secondary Outcomes (1)

  • Genetic testing

    5 months

Other Outcomes (1)

  • determination of the prevalence of hyperinsulinemia

    5 months

Study Arms (1)

obtention of a blood sample

all Atahualpa residents aged 40 years or more

Other: obtention of a blood sample

Interventions

obtention of a blood sampleOTHER

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

obtention of a blood sample

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all Atahualpa residents aged 40 years or more

You may qualify if:

  • Atahualpa resident aged 40 years or more

You may not qualify if:

  • non-consenting persons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center of Health

Atahualpa, Santa Elena, 0000, Ecuador

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Metabolic SyndromeDiabetes Mellitus

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Oscar H Del Brutto, MD

    Universidad de Especialidades Espiritu Santo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Rsearch Proffesor, Universidad de Especialidades Espiritu Santo

Study Record Dates

First Submitted

January 15, 2013

First Posted

January 17, 2013

Study Start

January 1, 2013

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

March 8, 2013

Record last verified: 2013-03

Locations

EC(1)