The Effect of Hyperglycemia on LV Function and Exercise Capacity in Diabetics With and Without Heart Failure.

Study Overview
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Brief Summary
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Diabetes and Heart Failure are diseases with high morbidity and increased risk of death. Former investigations has shown that diabetes worsens the prognosis of heart failure. However it is uncertain how short term diabetic dysregulation in type 2 diabetics affect cardiac function. Our hypothesis is that short term dysregulation affects left ventricular function and exercise capacity in insulin treated type 2 diabetics with and without heart failure. To elucidate this hypothesis diabetic patients with and without heart failure will be investigated after overnight state of either high or normal blood glucose levels on two separate occasions. Metabolic and hormonal parameters will be measured. Systolic and diastolic cardiac function will be assessed, exercise capacity and post exercise regional myocardial tissue velocity as well as 6 minutes walk test will be investigated on both occasions. The study will be a randomized cross-over design.

Official Title
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Metabolic Substrate Modulation in Insulin Treated Diabetics With and Without Heart Failure: The Effect of Hyperglycemia on Left Ventricular Function and Exercise Capacity.

Conditions
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Heart Failure, Type 2 Diabetes

Intervention / Treatment
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* Drug: insulin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Either normal ejection fraction (EF) or heart failure (EF =<45%) Insulin treated type 2 Exclusion Criteria: Forme stroke with significant physically or mentally disabilitating disorders advanced renal disease (creatinine levels >220 mM) advanced lever disease (alanine aminotransferase > 3 times over reference level). pregnancy other significant disabilitating disorders

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: euglycemia<br> | Drug: insulin<br>* There will be used individual intravenous insulin (actrapid) infusion to prevent non-intended hyperglycemia.<br>|
| Experimental: hyperglycemia<br> | Drug: insulin<br>* There will be used individual intravenous insulin (actrapid) infusion to prevent non-intended hyperglycemia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1: Cardiac systolic (EF by 2D and 3D echocardiography) and diastolic (e´/E and E/A) function before and after exercise. |  | 1-4 weeks | 
| Exercise capacity |  | 1-4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regional left ventricular function before and after maximum exercise(regional 2D tissue velocity and strain) |  | 1-4 weeks |