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Clinical Trials/NCT01213784
NCT01213784
Completed
Phase 2

Optimized Glycemic Control in Type 2 Diabetics With Heart Failure:"Effect on Left Ventricular Function and Skeletal Muscle"

University of Aarhus1 site in 1 country40 target enrollmentSeptember 2010

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Type 2 Diabetes
Sponsor
University of Aarhus
Enrollment
40
Locations
1
Primary Endpoint
Left ventricular function
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2010
End Date
November 2012
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Ejection fraction =\<45%
  • 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

Outcomes

Primary Outcomes

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 Outcomes

  • 6-minutes hall walk test(4 month)
  • Exercise capacity and peak oxygen consumption(4 month)
  • Muscle strength and mass(4 month)
  • hormonal and metabolic profile(4 month)

Study Sites (1)

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