Diabetes MellitusNCT01310556
Unknown Glucose Metabolism Disorders In Patients With Coronary Artery Disease
An observational study of Diabetes Mellitus, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to examine the prevalence of glucose metabolism disorders (GMD)in the patients with coronary artery disease and the relationship between different GMDs and coronary artery disease (CAD). Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- ogtt for patients with coronary artery disease
- How many people
- 230 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2009to Jun 2010
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with coronary artery disease and who had no glucose metabolism disorders.
Who may be able to join
- Patients with coronary artery disease and who had no glucose metabolism disorders were included to study.
Who cannot join
- Patients who had previous GMDs, malignancies, chronic liver and kidney diseases, rheumatologic disorders, and a BMI higher than 35 kg/m2 were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Previously Unknown Glucose Metabolism Disorders and Coronary Artery Disease in Patients Suffering From Coronary Artery Disease
This study aimed to examine the prevalence of glucose metabolism disorders (GMD)in the patients with coronary artery disease and the relationship between different GMDs and coronary artery disease (CAD).
Read the detailed description
Context: There are more than 220 million people diagnosed with diabetes mellitus (DM) in the world. DM is a serious risk factor for coronary artery disease (CAD). This study aimed to examine the prevalence of glucose metabolism disorders (GMD) in te patients with coronary artery disease and the relationship between different GMDs and CAD.
Settings: 230 patients with coronary artery disease and without any known GMDs were included the study. Coronary angiography was used to diagnose CAD. Patients were administered the 75 g Oral Glucose Tolerance Test (OGTT).
- Conditions
- Diabetes Mellitus
- Being tested
- ogtt for patients with coronary artery disease
- Keywords
- OGTT, coronary artery disease
- Medical subject headings
- Diabetes Mellitus, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ogtt for patients with coronary artery diseaseOther
Also called no name
75 g OGTT
| Study group | Role | What they receive |
|---|---|---|
| coronary artery disease | patients with coronary artery disease Receives: Other: ogtt for patients with coronary artery disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of unknown glucose metabolism disorders in patients with coronary artery disease
Results: While GMDs were detected in 58.26% (n=134 patients) of CAD patients, 41.74% of them (n=96 patients) were found to have normal glucose metabolism.
Measured: 1 year
Secondary outcomes (1)
Fasting and 120 minute glucose levels have relation with vessels' stenosis.
Fasting glucose level was found to have a significant correlation with the total number of stenotic coronary vessels (p=0.0001) and the stenosis rate of all vessels . OGTT 120-minute glucose levels were found to have a significant correlation with the total number of stenotic coronary vessels and the stenosis rate of vessels with the exception of LAD.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2011 (estimated)
- Study startJun 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhane School of Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Aydogan Aydogdu, MD, Study director, Gulhane School of Medicine Ankara/Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01310556
- Sponsor's protocol ID
- 12.05.2009-131-1068
- Status last verified
- Jun 2009
- First submitted
- 7 Mar 2011
- Last updated
- 21 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Previously Unknown Glucose Metabolism Disorders and Coronary Artery Disease in Patients Suffering From Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT01310556
- Acronym / sponsor ID
- 12.05.2009-131-1068
- Conditions
- Diabetes Mellitus
- Keywords
- OGTT, coronary artery disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 8 Mar 2011 (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.
This study aimed to examine the prevalence of glucose metabolism disorders (GMD)in the patients with coronary artery disease and the relationship between different GMDs and coronary artery disease (CAD).
Detailed description
Context: There are more than 220 million people diagnosed with diabetes mellitus (DM) in the world. DM is a serious risk factor for coronary artery disease (CAD). This study aimed to examine the prevalence of glucose metabolism disorders (GMD) in te patients with coronary artery disease and the relationship between different GMDs and CAD.
Settings: 230 patients with coronary artery disease and without any known GMDs were included the study. Coronary angiography was used to diagnose CAD. Patients were administered the 75 g Oral Glucose Tolerance Test (OGTT).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| coronary artery disease | – | Other: ogtt for patients with coronary artery diseasepatients with coronary artery disease |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with coronary artery disease and who had no glucose metabolism disorders.
Key inclusion criteria (1 listed)
- Patients with coronary artery disease and who had no glucose metabolism disorders were included to study.
Key exclusion criteria (1 listed)
- Patients who had previous GMDs, malignancies, chronic liver and kidney diseases, rheumatologic disorders, and a BMI higher than 35 kg/m2 were excluded from the study.
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 |
|---|---|---|
| ogtt for patients with coronary artery diseaseAlso: no name75 g OGTT | Other | coronary artery disease |
Primary outcome
Frequency of unknown glucose metabolism disorders in patients with coronary artery disease
Time frame: 1 year
Results: While GMDs were detected in 58.26% (n=134 patients) of CAD patients, 41.74% of them (n=96 patients) were found to have normal glucose metabolism.
1 secondary outcome
Fasting and 120 minute glucose levels have relation with vessels' stenosis.
Time frame: 1 year
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 21 Jun 2011.
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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.
Aydogan Aydogdu, MD study director
Gulhane School of Medicine Ankara/Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
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 1 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 21 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
Frequency of unknown glucose metabolism disorders in patients with coronary artery disease (time frame: 1 year). 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 21 Jun 2011.