Intensive Insulin Therapy in Non-diabetic Patients With Acute Myocardial Infarction and Hyperglycaemia (INSUCOR)

Hospital Clinic of Barcelona

Status and phase: Completed; Phase 4

Conditions: Diabetes; Hyperglycemia; Acute Myocardial Infarction

Treatments: Drug: Insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT00362778

The INSUCOR study

Details and patient eligibility

About

Hyperglycemia at admission has been associated with bad prognosis in patients with acute myocardial infarction (AMI). The clinical benefit of intensive treatment with insulin has been evaluated in diabetic patients admitted to intensive care units. The aim of our study was to assess the short-term effects and the safety of strict glycemic control in subjects with AMI and hyperglycemia without a previous history of diabetes.

Full description

Twenty-eight non-previously diabetic patients admitted with AMI and hyperglycemia were randomized to two treatment arms, administered during the first 48 hours: the intensive group (n=13) received intravenous insulin with target glycemia levels of 80-110mg/dL, while the conventional group (n=15) received subcutaneous insulin only when glycemia was ³ 160mg/dL. High-sensitivity C-reactive protein (HS-CRP) was determined at 48 hours and before discharge and an oral glucose tolerance test (OGTT) was performed at 1 month.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Confirmed diagnosis of AMI, either with or without ST segment elevation
2. Presence of high blood glucose at admission with no previously known diabetes mellitus (DM)

Exclusion criteria

1. Age under 18 years old
2. History of DM
3. Presence of other cardiopathies (dilated cardiomyopathy, valvular or hypertrophic heart disease)
4. Unstable AMI patients (haemodynamic instability or arrhythmic disorders)
5. Platelet aggregation or coagulation disorders
6. Severe conditions with an estimated short (under 1 year) life expectancy
7. Participation in other trials
8. Patient refusal to participate in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Serum saline

Sham Comparator group

Treatment:

Drug: Insulin