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

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ClinicalTrials.gov Identifier: NCT01071772
Recruitment Status : Completed
First Posted : February 19, 2010
Last Update Posted : June 9, 2011
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Study Description
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.

Condition or disease Intervention/treatment Phase
Heart Failure Type 2 Diabetes Drug: insulin Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : April 2009
Primary Completion Date : July 2010
Study Completion Date : July 2010

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: euglycemia Drug: insulin
There will be used individual intravenous insulin (actrapid) infusion to prevent non-intended hyperglycemia.
Experimental: hyperglycemia Drug: insulin
There will be used individual intravenous insulin (actrapid) infusion to prevent non-intended hyperglycemia.

Outcome Measures

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

Secondary Outcome Measures :
  1. Regional left ventricular function before and after maximum exercise(regional 2D tissue velocity and strain) [ Time Frame: 1-4 weeks ]

Eligibility Criteria

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01071772

Department ofCardiology, Aarhus University Hospital, Skejby
Aarhus, Region Midtjylland, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Danish Heart Foundation
Region midtjyllands sundhedsvidenskabelige forskningsfond
Study Director: Hans Erik Boedker, Prof, MD Dept. of cardiolgy, Aarhus University hospital, Skejby. Brendstrupgaardsvej 100, 8200 Aarhus N, Denmark
More Information

Responsible Party: Dr. Roni Ranghoej Nielsen, Dept. of cardiology, Aarhus University hospital, Skejby, Brendstrupgaardsvej 100, 8200 Aarhus N, Denmark
ClinicalTrials.gov Identifier: NCT01071772     History of Changes
Other Study ID Numbers: M20080151
First Posted: February 19, 2010    Key Record Dates
Last Update Posted: June 9, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs