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Completed

NCT Number: NCT01071772

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department ofCardiology, Aarhus University Hospital, Skejby

Aarhus, Central Jutland, 8200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insulin

Drug

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

Primary outcomes

  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 outcomes

  1. Regional left ventricular function before and after maximum exercise(regional 2D tissue velocity and strain)

    Time frame: 1-4 weeks

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Danish Heart Foundation
  • Region midtjyllands sundhedsvidenskabelige forskningsfond

Registry information

Official study title

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

Acronym: METAMOD

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 19, 2010
Registry last updated
Jun 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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