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Completed

NCT Number: NCT00362778

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Insulin

Drug

intravenous continuous insulin infusion for 48 hours

Primary outcomes

  1. Glycemic control

    Time frame: first 48 hours

Secondary outcomes

  1. High-sensitivity C-reactive protein levels

    Time frame: At 48 hours and aat hospital discharge

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Acronym: INSUCOR

Important dates

Study start
2006
Primary completion
2006
Study completion
2007
First posted
Aug 10, 2006
Registry last updated
Mar 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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