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

Phase 4

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Device: Continuous Glucose Monitoring System (i Pro 2 - Medtronic)

• Registration Number: NCT02932592
• Lead Sponsor: University of Pavia

Brief Summary

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

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 Timeline

• Study Start: 2016-03-16
• Study First Submitted: 2016-09-30
• Study First Submitted QC: 2016-10-11
• Study First Posted: 2016-10-13
• Primary Completion: 2017-03-25
• Study Completion: 2017-10-31
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-21
• Last Update Posted: 2022-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

• nondiabetic patients
• acute coronary syndrome

Exclusion Criteria

• diabetic patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dysglycemic group	Continuous Glucose Monitoring System (i Pro 2 - Medtronic)	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.

Primary Outcome Measures

Name	Time	Method
Glycemic status	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.

Secondary Outcome Measures

Name	Time	Method
Lipid profile	15 days	Lipoprotein (a)
Endothelial damage	15 days	sVCAM-1
Inflammation parameters	15 days	TNF-alfa
Heart damage	15 days	I troponin

Trial Locations

Locations (1)

Giuseppe Derosa; 🇮🇹 Pavia, Italy