NCT02855879

Brief 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). In addition, the effect of these anomalies on post CABG morbi/mortality in the short term will be evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
286

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

April 8, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 4, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2019

Completed
Last Updated

December 11, 2019

Status Verified

December 1, 2019

Enrollment Period

4.2 years

First QC Date

July 28, 2016

Last Update Submit

December 10, 2019

Conditions

Anomalies in Glucose MetabolismCoronary Artery Bypass Graft

Outcome Measures

Primary Outcomes (1)

  • Percentage of glucose anomalies (non-diabetic fasting hyperglycaemia, glucose intolerance, diabetes) in CAD patients about to undergo coronary artery bypass grafting.

    Change from inclusion to week 2 and up to month 3

Study Arms (1)

CAD patients

Other: Collection of biological dataOther: Collection of clinical data

Interventions

Collection of biological dataOTHER
CAD patients
Collection of clinical dataOTHER
CAD patients

Eligibility Criteria

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

patients about to undergo coronary artery bypass grafting

You may qualify if:

  • persons who have provided oral consent
  • patients about to undergo coronary artery bypass grafting
  • age \>18 years

You may not qualify if:

  • persons without national health insurance cover
  • Adults under guardianship
  • Pregnant or breast-feeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21079, France

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2016

First Posted

August 4, 2016

Study Start

April 8, 2015

Primary Completion

June 5, 2019

Study Completion

June 5, 2019

Last Updated

December 11, 2019

Record last verified: 2019-12

Locations

FR(1)