Prevalence of Metabolic Syndrome in Atahualpa | NCT01770054

Studies
Prevalence of Metabolic Syndrome in Atahualpa

NCT01770054

Sponsor

Hospital Clínica Kennedy

Status

Completed

Last Update Posted

Mar 8, 2013Estimated

Enrollment

517Actual

Phase

Not provided

Conditions

Metabolic Syndrome

Interventions

obtention of a blood sample

Countries

Ecuador

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
001-2013-01	Other Grant/Funding Number	Universidad de Especialidades Espiritu Santo

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Mar 2013Actual

Completion Date

Mar 2013Actual

First Submitted Date

Jan 15, 2013

First Submission Date that Met QC Criteria

Jan 16, 2013

First Posted Date

Jan 17, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 7, 2013

Last Update Posted Date

Mar 8, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Oscar H. Del Brutto, MD, Rsearch Proffesor, Universidad de Especialidades Espiritu Santo, Hospital Clínica KennedyPrincipal Investigator

Lead Sponsor

Hospital Clínica KennedyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

517Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
obtention of a blood sample		all Atahualpa residents aged 40 years or more	Other: obtention of a blood sample

Interventions

Name	Type	Description	Arm Group Labels	Other Names
obtention of a blood sample	Other	a blood sample will be obtained to measure glucose, HDL cholesterol, triglycerides, and for genetic testing	obtention of a blood sample

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Atahualpa resident aged 40 years or more

Exclusion Criteria:

non-consenting persons

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

all Atahualpa residents aged 40 years or more

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Oscar H Del Brutto, MD	Universidad de Especialidades Espiritu Santo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center of Health		Atahualpa	Santa Elena	0000	Ecuador

Condition Browse Module

MeSH Terms

ID	Term
D024821	Metabolic Syndrome
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D007333	Insulin Resistance
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

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