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Clinical Trials/NCT01213784
NCT01213784CompletedPhase 2

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

University of Aarhus2 sites in 1 country40 target enrollmentStarted: September 2010Last updated:
Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
40
Locations
2
Primary Endpoint
Left ventricular function

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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