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

NCT ID: NCT01071772

Last Updated: 2011-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2010-07-31

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.

Conditions

Heart Failure; Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

euglycemia

Group Type: EXPERIMENTAL

insulin

Intervention Type: DRUG

There will be used individual intravenous insulin (actrapid) infusion to prevent non-intended hyperglycemia.

hyperglycemia

Group Type: EXPERIMENTAL

insulin

Intervention Type: DRUG

There will be used individual intravenous insulin (actrapid) infusion to prevent non-intended hyperglycemia.

Interventions

insulin

There will be used individual intravenous insulin (actrapid) infusion to prevent non-intended hyperglycemia.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Danish Heart Foundation

OTHER

Sponsor Role: collaborator

Region midtjyllands sundhedsvidenskabelige forskningsfond

UNKNOWN

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Dept. of cardiology, Aarhus University hospital, Skejby, Brendstrupgaardsvej 100, 8200 Aarhus N, Denmark

Principal Investigators

Hans Erik Boedker, Prof, MD

Role: STUDY_DIRECTOR

Dept. of cardiolgy, Aarhus University hospital, Skejby. Brendstrupgaardsvej 100, 8200 Aarhus N, Denmark

Locations

Department ofCardiology, Aarhus University Hospital, Skejby

Aarhus, Central Jutland, Denmark

Countries

Denmark

Other Identifiers

M20080151

Identifier Type: -

Identifier Source: org_study_id