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
• 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

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

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