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

Primary Purpose

Heart Failure, Type 2 Diabetes

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
insulin
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department ofCardiology, Aarhus University Hospital, Skejby

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

euglycemia

hyperglycemia

Arm Description

Outcomes

Primary Outcome Measures

1: Cardiac systolic (EF by 2D and 3D echocardiography) and diastolic (e´/E and E/A) function before and after exercise.
Exercise capacity

Secondary Outcome Measures

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

Full Information

First Posted
February 16, 2010
Last Updated
June 8, 2011
Sponsor
University of Aarhus
Collaborators
Danish Heart Foundation, Region midtjyllands sundhedsvidenskabelige forskningsfond
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1. Study Identification

Unique Protocol Identification Number
NCT01071772
Brief Title
The Effect of Hyperglycemia on LV Function and Exercise Capacity in Diabetics With and Without Heart Failure.
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Aarhus
Collaborators
Danish Heart Foundation, Region midtjyllands sundhedsvidenskabelige forskningsfond

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Type 2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
euglycemia
Arm Type
Experimental
Arm Title
hyperglycemia
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
insulin
Intervention Description
There will be used individual intravenous insulin (actrapid) infusion to prevent non-intended hyperglycemia.
Primary Outcome Measure Information:
Title
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
Title
Exercise capacity
Time Frame
1-4 months
Secondary Outcome Measure Information:
Title
Regional left ventricular function before and after maximum exercise(regional 2D tissue velocity and strain)
Time Frame
1-4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans Erik Boedker, Prof, MD
Organizational Affiliation
Dept. of cardiolgy, Aarhus University hospital, Skejby. Brendstrupgaardsvej 100, 8200 Aarhus N, Denmark
Official's Role
Study Director
Facility Information:
Facility Name
Department ofCardiology, Aarhus University Hospital, Skejby
City
Aarhus
State/Province
Region Midtjylland
ZIP/Postal Code
8200
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

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

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