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Optimized Glycemic Control in Heart Failure Patients With DM2:"Effect on Left Ventricular Function and Skeletal Muscle" (HFDM)

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ClinicalTrials.gov Identifier: NCT01213784
Recruitment Status : Completed
First Posted : October 4, 2010
Last Update Posted : March 6, 2015
Sponsor:
Collaborator:
The Danish Diabetes Association
Information provided by (Responsible Party):
University of Aarhus

Study Description
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Brief Summary:

The investigators wish to investigate wether a more strict diabetic control improves cardiac function, muscle strength, exercise capacity and decreases symptoms.

The investigators hypothesis is that improving the glycemic control in suboptimized diabetics with heart failure will improve cardiac performance, muscle strength, exercise capacity and decrease symptoms.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Heart Failure Other: all antidiabetic drugs will be appliable Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimized Glycemic Control in Type 2 Diabetics With Heart Failure:"Effect on Left Ventricular Function and Skeletal Muscle"
Study Start Date : September 2010
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Arm Intervention/treatment
Experimental: optimized diabetic control
each participant will be assigned to be optimized in a dedicated diabetic clinic
 Other: all antidiabetic drugs will be appliable
We expect all participants to be set on insulin during the intervention, however all types of insulin and other antidiabetics can be used goal: Hba1c lower than 7,5%
No Intervention: control
participants will be assigned to follow what ever control they were in before the study and not to change any antidiabetic treatment during the interventions period.


Outcome Measures
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Primary Outcome Measures :
  1. Left ventricular function [ Time Frame: 4 month ]

    Left ventricular function will be evaluated using echocardiografi measuring:

    - 2D Ejection fraction (using an ultrasound agent), global and regional tissue velocity, Strain / strain rate - all measures done during rest and dobutamin stress test.



Secondary Outcome Measures :
  1. hormonal and metabolic profile [ Time Frame: 4 month ]
    bloodsamples

  2. 6-minutes hall walk test [ Time Frame: 4 month ]
    using a hall walk protocol

  3. Exercise capacity and peak oxygen consumption [ Time Frame: 4 month ]
    using a treadmill test and continues oxygen consumption measurement

  4. Muscle strength and mass [ Time Frame: 4 month ]
    muscle strength: hand grip test


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ejection fraction =<45%
  • Diabetes
  • Hba1c =>7,5%
  • In anticongestive treatment
  • NYHA class 2-4

Exclusion Criteria:

  • Severe angina (CCS 3-4)
  • Hemodynamic significant heart valve disease
  • Congenital heart disease
  • Pregnancy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01213784


Locations
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Denmark
Dept. of cardiology, Aarhus university hospital Skejby
Aarhus, Region Midtjylland, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
The Danish Diabetes Association
Investigators
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Principal Investigator: Roni R Nielsen, MD Dept. of cardiology, University hospital Aarhus Skejby
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01213784    
Other Study ID Numbers: M20090047
First Posted: October 4, 2010    Key Record Dates
Last Update Posted: March 6, 2015
Last Verified: June 2013
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Hypoglycemic Agents
Physiological Effects of Drugs