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

This study has been completed.
Sponsor:
Collaborators:
Danish Heart Foundation
Region midtjyllands sundhedsvidenskabelige forskningsfond
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01071772
First received: February 16, 2010
Last updated: June 8, 2011
Last verified: June 2011
History of Changes
  Purpose

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 Intervention Phase
Heart Failure
Type 2 Diabetes
 Drug: insulin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Exercise capacity [ Time Frame: 1-4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Regional left ventricular function before and after maximum exercise(regional 2D tissue velocity and strain) [ Time Frame: 1-4 weeks ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: April 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01071772

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

No publications provided

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
Study First Received: February 16, 2010
Last Updated: June 8, 2011
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Heart Failure
Hyperglycemia
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Heart Diseases
Cardiovascular Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013