- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02486237
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
Conditions
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
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-
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San José, Costa Rica
- Hospital CIMA
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San José
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San Pedro de Montes de Oca, San José, Costa Rica, 1406-1200
- Clínica Los Yoses
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-
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San Salvador, El Salvador
- Centro Panamericano de Ojos
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San Salvador, El Salvador
- INSACOR
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San Salvador, El Salvador
- Medicentro La Esperanza
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-
-
-
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Guatemala, Guatemala
- Clínica 1005
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Guatemala, Guatemala
- Prevención en Salud S.A
-
-
-
-
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Tegucigalpa, Honduras
- Honduras Medical Center
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-
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.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 001 (NavyGHB)
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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