NCT02486237

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Shorter than P25 for all trials

Geographic Reach
4 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 1, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

July 27, 2016

Status Verified

July 1, 2016

Enrollment Period

7 months

First QC Date

June 22, 2015

Last Update Submit

July 25, 2016

Conditions

Diabetes Mellitus, Type 2

Keywords

diabetes mellituscomplicationsprevalence

Outcome Measures

Primary Outcomes (1)

  • Number of patients with microvascular and cardiovascular complications

    up to 10 years

Secondary Outcomes (5)

  • Number of participants with at least one episode of hypoglycemia

    up to 10 years

  • Number of patients with microvascular and cardiovascular complications stratified by their glucose control

    up to 10 years

  • Number of patients with microvascular and cardiovascular complications stratified by blood pressure control

    up to 10 years

  • Number of patients with microvascular and cardiovascular complications stratified by cholesterol levels

    up to 10 years

  • Number of patients with microvascular and cardiovascular complications stratified by diabetes pharmacologic treatment

    up to 10 years

Study Arms (1)

Type 2 diabetes mellitus

Type 2 diabetes mellitus patients, no intervention is performed besides usual clinical practice

Other: None, observational study

Interventions

None, observational studyOTHER

None, it is an observational study

Type 2 diabetes mellitus

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with type 2 diabetes mellitus

You may qualify if:

  • 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Hospital CIMA

San José, Provincia de San José, Costa Rica

Location

Clínica Los Yoses

San Pedro, Provincia de San José, 1406-1200, Costa Rica

Location

Centro Panamericano de Ojos

San Salvador, San Salvador Department, El Salvador

Location

INSACOR

San Salvador, San Salvador Department, El Salvador

Location

Medicentro La Esperanza

San Salvador, San Salvador Department, El Salvador

Location

Clínica 1005

Guatemala City, Departamento de Guatemala, Guatemala

Location

Prevención en Salud S.A

Guatemala City, Departamento de Guatemala, Guatemala

Location

Honduras Medical Center

Tegucigalpa, Francisco Morazán Department, Honduras

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

Observation

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Chih Hao Chen Ku, MD

    Clínica Los Yoses

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 22, 2015

First Posted

July 1, 2015

Study Start

September 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

July 27, 2016

Record last verified: 2016-07

Locations

GU(2)CO(2)HO(1)EL(3)