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

Heart Failure Clinical Trial

— METAMOD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01071772
• Other study ID #: M20080151
• Status: Completed
• Phase: Phase 2
• First received: February 16, 2010
• Last updated: June 8, 2011
• Start date: April 2009
• Est. completion date: July 2010

Study information

• Verified date: June 2011
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Hyperglycemia
• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
Denmark	Department ofCardiology, Aarhus University Hospital, Skejby	Aarhus	Region Midtjylland

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Danish Heart Foundation, Region midtjyllands sundhedsvidenskabelige forskningsfond

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1: Cardiac systolic (EF by 2D and 3D echocardiography) and diastolic (e´/E and E/A) function before and after exercise.		1-4 weeks	No
Primary	Exercise capacity		1-4 months	No
Secondary	Regional left ventricular function before and after maximum exercise(regional 2D tissue velocity and strain)		1-4 weeks	No