Optimized Glycemic Control in Type 2 Diabetics With Heart Failure:"Effect on Left Ventricular Function and Skeletal Muscle"
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Aarhus
- Enrollment
- 40
- Locations
- 1
- 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
Arms & Interventions
optimized diabetic control
each participant will be assigned to be optimized in a dedicated diabetic clinic
Intervention: all antidiabetic drugs will be appliable (Other)
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.
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
- Exercise capacity and peak oxygen consumption(4 month)
- 6-minutes hall walk test(4 month)
- hormonal and metabolic profile(4 month)
- Muscle strength and mass(4 month)