Complications in Central American Diabetic Patients: Historic Cohort

July 25, 2016 updated by: Chih Hao Chen Ku, Clínica Los Yoses
Retrospective, observational study to determine the prevalence of complications in Central American diabetic patients.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

This is retrospective observational study aimed to determine the prevalence of complications in Central American diabetic patients. Patients included are treated in the usual outpatient practice setting and we will try to determine the prevalence of diabetic complications in these patients.

Study Type

Observational

Enrollment (Actual)

225

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

      • San José, Costa Rica
        • Hospital CIMA
    • San José
      • San Pedro de Montes de Oca, San José, Costa Rica, 1406-1200
        • Clínica Los Yoses
      • San Salvador, El Salvador
        • Centro Panamericano de Ojos
      • San Salvador, El Salvador
        • INSACOR
      • San Salvador, El Salvador
        • Medicentro La Esperanza
      • Guatemala, Guatemala
        • Clínica 1005
      • Guatemala, Guatemala
        • Prevención en Salud S.A
      • Tegucigalpa, Honduras
        • Honduras Medical Center

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients with type 2 diabetes mellitus

Description

Inclusion Criteria:

  • type 2 diabetes mellitus diagnosed between 2004 and 2009
  • seen by the attending physician for the first time between January and December 2009.
  • male or female patients between 18 and 80 years

Exclusion Criteria:

  • none

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Type 2 diabetes mellitus
Type 2 diabetes mellitus patients, no intervention is performed besides usual clinical practice
None, it is an observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with microvascular and cardiovascular complications
Time Frame: up to 10 years
up to 10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with at least one episode of hypoglycemia
Time Frame: up to 10 years
up to 10 years
Number of patients with microvascular and cardiovascular complications stratified by their glucose control
Time Frame: up to 10 years
up to 10 years
Number of patients with microvascular and cardiovascular complications stratified by blood pressure control
Time Frame: up to 10 years
up to 10 years
Number of patients with microvascular and cardiovascular complications stratified by cholesterol levels
Time Frame: up to 10 years
up to 10 years
Number of patients with microvascular and cardiovascular complications stratified by diabetes pharmacologic treatment
Time Frame: up to 10 years
up to 10 years

Collaborators and Investigators

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

Collaborators

Investigators

  • Principal Investigator: Chih Hao Chen Ku, MD, Clínica Los Yoses

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

September 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

June 22, 2015

First Submitted That Met QC Criteria

June 26, 2015

First Posted (Estimate)

July 1, 2015

Study Record Updates

Last Update Posted (Estimate)

July 27, 2016

Last Update Submitted That Met QC Criteria

July 25, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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