evAluation of Glycemic RangE During acutE Coronary syndroME in Nondiabetic paTients (AGREEMENT) (AGREEMENT)

May 21, 2022 updated by: Giuseppe Derosa, University of Pavia

evAluation of Glycemic RangE During acutE Coronary syndroME in Nondiabetic paTients

To evaluate the glycemic variations during acute coronary syndrome in non-diabetic patients (euglycemic, or with impaired fasting glucose, or with impaired glucose tolerance)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All nondiabetic patients with dysglycemia (fasting plasma glucose between 100 and 125 mg/dl) will be monitored with a device (Continuous Glucose Monitoring System) and all these patients will be undergone an oral glucose tolerance test after the discharge from this Unit.

Study Type

Interventional

Enrollment (Actual)

196

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Pavia, Italy, 27100
        • Giuseppe Derosa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • nondiabetic patients
  • acute coronary syndrome

Exclusion Criteria:

  • diabetic patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dysglycemic group

Patients with dysglycemia (not diabetic patients) will be undergone a monitoring of blood glucose with a device till the discharge of the patient.

Then, an oral glucose tolerance test (OGTT) will be done to categorize the patient as having impaired fasting glucose (IFG) or impaired glucose tolerance (IGT), or diabetes mellitus.
Device: Continuous Glucose Monitoring System (i Pro 2 - Medtronic)
This device can register blood glucose values and excursions. This device consists of a needle (applied in subcutaneous way) and of a recording device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic status
Time Frame: 15 days

Patients with dysglycemia (not diabetic patients) will be undergone a monitoring of blood glucose with a device till the discharge of the patient.

Then, an oral glucose tolerance test (OGTT) will be done to categorize the patient as having impaired fasting glucose (IFG) or impaired glucose tolerance (IGT), or diabetes mellitus.
15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lipid profile
Time Frame: 15 days
Total cholesterol
15 days
Lipid profile
Time Frame: 15 days
HDL-cholesterol
15 days
Lipid profile
Time Frame: 15 days
Triglycerides
15 days
Lipid profile
Time Frame: 15 days
Lipoprotein (a)
15 days
Endothelial damage
Time Frame: 15 days
sICAM-1
15 days
Endothelial damage
Time Frame: 15 days
sVCAM-1
15 days
Inflammation parameters
Time Frame: 15 days
sRAGE
15 days
Inflammation parameters
Time Frame: 15 days
sCD40L
15 days
Inflammation parameters
Time Frame: 15 days
MPO
15 days
Inflammation parameters
Time Frame: 15 days
hs-CRP
15 days
Inflammation parameters
Time Frame: 15 days
IL-6
15 days
Inflammation parameters
Time Frame: 15 days
TNF-alfa
15 days
Heart damage
Time Frame: 15 days
CPK
15 days
Heart damage
Time Frame: 15 days
I troponin
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pavia

Investigators

  • Principal Investigator: Giuseppe Derosa, MD, PhD, FESC, University of Pavia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2016

Primary Completion (Actual)

March 25, 2017

Study Completion (Actual)

October 31, 2017

Study Registration Dates

First Submitted

September 30, 2016

First Submitted That Met QC Criteria

October 11, 2016

First Posted (Estimate)

October 13, 2016

Study Record Updates

Last Update Posted (Actual)

May 26, 2022

Last Update Submitted That Met QC Criteria

May 21, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20160000072

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe