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NCT02486237 Clinical Trial

Complications in Central American Diabetic Patients: Historic Cohort

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
Complications in Central American Diabetic Patients: Historic Cohort

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02486237
Other study ID # 001
Secondary ID
Status Completed
Phase N/A
First received June 22, 2015
Last updated July 25, 2016
Start date September 2015
Est. completion date April 2016

Study information
Verified date July 2016
Source Clínica Los Yoses
Contact n/a
Is FDA regulated No
Health authority Costa Rica: Ethics Committee
Study type Observational

Clinical Trial Summary

Retrospective, observational study to determine the prevalence of complications in Central American diabetic patients.

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.

Recruitment information / eligibility
Status Completed
Enrollment 225
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Other:
• None, observational study
None, it is an observational study

Locations
Country Name City State
Costa Rica Hospital CIMA San José
Costa Rica Clínica Los Yoses San Pedro de Montes de Oca San José
El Salvador Centro Panamericano de Ojos San Salvador
El Salvador INSACOR San Salvador
El Salvador Medicentro La Esperanza San Salvador
Guatemala Clínica 1005 Guatemala
Guatemala Prevención en Salud S.A Guatemala
Honduras Honduras Medical Center Tegucigalpa

Sponsors (2)
Lead Sponsor Collaborator
Clínica Los Yoses Novo Nordisk A/S

Countries where clinical trial is conducted

Costa Rica,  El Salvador,  Guatemala,  Honduras, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients with microvascular and cardiovascular complications up to 10 years No
Secondary Number of participants with at least one episode of hypoglycemia up to 10 years No
Secondary Number of patients with microvascular and cardiovascular complications stratified by their glucose control up to 10 years No
Secondary Number of patients with microvascular and cardiovascular complications stratified by blood pressure control up to 10 years No
Secondary Number of patients with microvascular and cardiovascular complications stratified by cholesterol levels up to 10 years No
Secondary Number of patients with microvascular and cardiovascular complications stratified by diabetes pharmacologic treatment up to 10 years No
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