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

June 8, 2011 updated by: University of Aarhus

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Region Midtjylland
      • Aarhus, Region Midtjylland, Denmark, 8200
        • Department ofCardiology, Aarhus University Hospital, Skejby

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1-4 weeks
Exercise capacity
Time Frame: 1-4 months
1-4 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

February 16, 2010

First Submitted That Met QC Criteria

February 18, 2010

First Posted (Estimate)

February 19, 2010

Study Record Updates

Last Update Posted (Estimate)

June 9, 2011

Last Update Submitted That Met QC Criteria

June 8, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M20080151

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

Clinical Trials on insulin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe