Diabetes Mellitus, Type 2NCT02486237
Complications in Central American Diabetic Patients: Historic Cohort
An observational study of Diabetes Mellitus, Type 2, run by Clínica Los Yoses at 8 sites in 4 countries.
Trial summary
Retrospective, observational study to determine the prevalence of complications in Central American diabetic patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- None, observational study
- How many people
- 225 participants
- Where
- 8 sitesin 4 countries
- Study dates
- Sep 2015to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with type 2 diabetes mellitus
Who may be able to join
- 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
Who cannot join
- none
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
El Salvador3 sites
Centro Panamericano de Ojos
San Salvador, San Salvador Department
INSACOR
San Salvador, San Salvador Department
Medicentro La Esperanza
San Salvador, San Salvador Department
Costa Rica2 sites
Hospital CIMA
San José, Provincia de San José
Clínica Los Yoses
San Pedro, Provincia de San José, 1406-1200
Guatemala2 sites
Clínica 1005
Guatemala City, Departamento de Guatemala
Prevención en Salud S.A
Guatemala City, Departamento de Guatemala
Honduras1 site
Honduras Medical Center
Tegucigalpa, Francisco Morazán Department
About this study
Retrospective, observational study to determine the prevalence of complications in Central American diabetic patients.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- None, observational study
- Keywords
- diabetes mellitus, complications, prevalence
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None, observational studyOther
None, it is an observational study
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetes mellitus | Type 2 diabetes mellitus patients, no intervention is performed besides usual clinical practice Receives: Other: None, observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with microvascular and cardiovascular complications
Measured: up to 10 years
Secondary outcomes (5)
Number of participants with at least one episode of hypoglycemia
Measured: up to 10 years
Number of patients with microvascular and cardiovascular complications stratified by their glucose control
Measured: up to 10 years
Number of patients with microvascular and cardiovascular complications stratified by blood pressure control
Measured: up to 10 years
Number of patients with microvascular and cardiovascular complications stratified by cholesterol levels
Measured: up to 10 years
Number of patients with microvascular and cardiovascular complications stratified by diabetes pharmacologic treatment
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startSep 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clínica Los Yoses
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Principal investigator, Chih Hao Chen Ku, Clínica Los Yoses
- Investigators
- Chih Hao Chen Ku, MD, Principal investigator, Clínica Los Yoses
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02486237
- Sponsor's protocol ID
- 001
- Status last verified
- Jul 2016
- First submitted
- 22 Jun 2015
- Last updated
- 27 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complications in Central American Diabetic Patients: Historic Cohort
- ClinicalTrials.gov ID
- NCT02486237
- Acronym / sponsor ID
- 001
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- diabetes mellitus, complications, prevalence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Clínica Los YosesUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- Sep 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 1 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Retrospective, observational study to determine the prevalence of complications in Central American diabetic patients.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetes mellitus | – | Other: None, observational studyType 2 diabetes mellitus patients, no intervention is performed besides usual clinical practice |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with type 2 diabetes mellitus
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None, observational studyNone, it is an observational study | Other | Type 2 diabetes mellitus |
Primary outcome
Number of patients with microvascular and cardiovascular complications
Time frame: up to 10 years
5 secondary outcomes
Number of participants with at least one episode of hypoglycemia
Time frame: up to 10 years
Number of patients with microvascular and cardiovascular complications stratified by their glucose control
Time frame: up to 10 years
Number of patients with microvascular and cardiovascular complications stratified by blood pressure control
Time frame: up to 10 years
Number of patients with microvascular and cardiovascular complications stratified by cholesterol levels
Time frame: up to 10 years
Number of patients with microvascular and cardiovascular complications stratified by diabetes pharmacologic treatment
Time frame: up to 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chih Hao Chen Ku, MD principal investigator
Clínica Los Yoses
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Clínica Los Yoses at 8 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in El Salvador, Costa Rica, Guatemala, Honduras. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with microvascular and cardiovascular complications (time frame: up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2016.