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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01071772
Recruitment Status : Completed
First Posted : February 19, 2010
Last Update Posted : June 9, 2011
Sponsor:
Collaborators:
Danish Heart Foundation
Region midtjyllands sundhedsvidenskabelige forskningsfond
Information provided by:
University of Aarhus

Tracking Information
First Submitted Date  ICMJE February 16, 2010
First Posted Date  ICMJE February 19, 2010
Last Update Posted Date June 9, 2011
Study Start Date  ICMJE April 2009
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2010)
  • 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 ]
  • Exercise capacity [ Time Frame: 1-4 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 18, 2010)
  • 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 ]
  • Exercise capacity [ Time Frame: 1-4 months ]
  • Maximum oxygen consumption and cardiac output. [ Time Frame: 1-4 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2010)
Regional left ventricular function before and after maximum exercise(regional 2D tissue velocity and strain) [ Time Frame: 1-4 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Hyperglycemia on LV Function and Exercise Capacity in Diabetics With and Without Heart Failure.
Official Title  ICMJE Metabolic Substrate Modulation in Insulin Treated Diabetics With and Without Heart Failure: The Effect of Hyperglycemia on Left Ventricular Function and Exercise Capacity.
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Heart Failure
  • Type 2 Diabetes
Intervention  ICMJE Drug: insulin
There will be used individual intravenous insulin (actrapid) infusion to prevent non-intended hyperglycemia.
Study Arms  ICMJE
  • Experimental: euglycemia
    Intervention: Drug: insulin
  • Experimental: hyperglycemia
    Intervention: Drug: insulin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 24, 2010)
18
Original Estimated Enrollment  ICMJE
 (submitted: February 18, 2010)
23
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01071772
Other Study ID Numbers  ICMJE M20080151
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Roni Ranghoej Nielsen, Dept. of cardiology, Aarhus University hospital, Skejby, Brendstrupgaardsvej 100, 8200 Aarhus N, Denmark
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE
  • Danish Heart Foundation
  • Region midtjyllands sundhedsvidenskabelige forskningsfond
Investigators  ICMJE
Study Director: Hans Erik Boedker, Prof, MD Dept. of cardiolgy, Aarhus University hospital, Skejby. Brendstrupgaardsvej 100, 8200 Aarhus N, Denmark
PRS Account University of Aarhus
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP