Anomalies in Glucose MetabolismIMPACTNCT02855879
Evaluation of the Prevalence of anomalIes of Glucose Metabolism in Patients Undergoing a Coronary Artery Bypass Graft (CABG)
An observational study of Anomalies in Glucose Metabolism and Coronary Artery Bypass Graft, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The aim of this study is to determine the prevalence of diabetes and non-diabetic glucose metabolism anomalies (glucose intolerance, non-diabetic fasting hyperglycaemia in patients about to undergo coronary artery bypass grafting (CABG). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anomalies in Glucose Metabolism, Coronary Artery Bypass Graft
- What is being tested?
- Collection of biological data and Collection of clinical data
- How many people
- 286 participants
- Where
- 1 siteFrance
- Study dates
- 8 Apr 2015to 5 Jun 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients about to undergo coronary artery bypass grafting
Who may be able to join
- persons who have provided oral consent
- patients about to undergo coronary artery bypass grafting
- age >18 years
Who cannot join
- persons without national health insurance cover
- Adults under guardianship
- Pregnant or breast-feeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Prevalence of anomalIes of Glucose Metabolism in Patients Undergoing a Coronary Artery Bypass Graft, Consequences for Morbi/Mortality in the Short and Medium Term
The aim of this study is to determine the prevalence of diabetes and non-diabetic glucose metabolism anomalies (glucose intolerance, non-diabetic fasting hyperglycaemia in patients about to undergo coronary artery bypass grafting (CABG).
In addition, the effect of these anomalies on post CABG morbi/mortality in the short term will be evaluated.
- Being tested
- Collection of biological data, Collection of clinical data
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of biological dataOther
Collection of clinical dataOther
| Study group | Role | What they receive |
|---|---|---|
| CAD patients | Not described Receives: Other: Collection of biological data; Other: Collection of clinical data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of glucose anomalies (non-diabetic fasting hyperglycaemia, glucose intolerance, diabetes) in CAD patients about to undergo coronary artery bypass grafting.
Measured: Change from inclusion to week 2 and up to month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study start8 Apr 2015
- Primary completion5 Jun 2019
- Study completion5 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anomalies in Glucose MetabolismStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02855879
- Sponsor's protocol ID
- VERGES 2014
- Acronym
- IMPACT
- Status last verified
- Dec 2019
- First submitted
- 28 Jul 2016
- Last updated
- 11 Dec 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Prevalence of anomalIes of Glucose Metabolism in Patients Undergoing a Coronary Artery Bypass Graft, Consequences for Morbi/Mortality in the Short and Medium Term
- ClinicalTrials.gov ID
- NCT02855879
- Acronym / sponsor ID
- IMPACT / VERGES 2014
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 8 Apr 2015 (actual)
- Primary completion
- 5 Jun 2019 (actual)
- Study completion
- 5 Jun 2019 (actual)
- First posted
- 4 Aug 2016 (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.
The aim of this study is to determine the prevalence of diabetes and non-diabetic glucose metabolism anomalies (glucose intolerance, non-diabetic fasting hyperglycaemia in patients about to undergo coronary artery bypass grafting (CABG).
In addition, the effect of these anomalies on post CABG morbi/mortality in the short term will be evaluated.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAD patients | – | Other: Collection of biological data, Other: Collection of clinical data |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients about to undergo coronary artery bypass grafting
Key inclusion criteria (3 listed)
- persons who have provided oral consent
- patients about to undergo coronary artery bypass grafting
- age >18 years
Key exclusion criteria (3 listed)
- persons without national health insurance cover
- Adults under guardianship
- Pregnant or breast-feeding women
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 |
|---|---|---|
| Collection of biological data | Other | CAD patients |
| Collection of clinical data | Other | CAD patients |
Primary outcome
Percentage of glucose anomalies (non-diabetic fasting hyperglycaemia, glucose intolerance, diabetes) in CAD patients about to undergo coronary artery bypass grafting.
Time frame: Change from inclusion to week 2 and up to month 3
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 11 Dec 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Anomalies in Glucose Metabolism and Coronary Artery Bypass Graft, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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 3 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 11 Dec 2019. 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 France. 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?
Percentage of glucose anomalies (non-diabetic fasting hyperglycaemia, glucose intolerance, diabetes) in CAD patients about to undergo coronary artery bypass grafting. (time frame: Change from inclusion to week 2 and up to month 3). 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 11 Dec 2019.