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

Phase 2

Completed

• Conditions: Heart Failure; Type 2 Diabetes
• Interventions: Drug: insulin

• Registration Number: NCT01071772
• Lead Sponsor: University of Aarhus

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2010-02-16
• Study First Submitted QC: 2010-02-18
• Study First Posted: 2010-02-19
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-08
• Last Update Posted: 2011-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
euglycemia	insulin	-
hyperglycemia	insulin	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Regional left ventricular function before and after maximum exercise(regional 2D tissue velocity and strain)	1-4 weeks

Trial Locations

Locations (1)

Department ofCardiology, Aarhus University Hospital, Skejby; 🇩🇰 Aarhus, Region Midtjylland, Denmark