Optimized Glycemic Control in Heart Failure Patients With DM2:"Effect on Left Ventricular Function and Skeletal Muscle" (HFDM)
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.
|Type 2 Diabetes Heart Failure||Other: all antidiabetic drugs will be appliable||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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"|
- 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.
- hormonal and metabolic profile [ Time Frame: 4 month ]bloodsamples
- 6-minutes hall walk test [ Time Frame: 4 month ]using a hall walk protocol
- Exercise capacity and peak oxygen consumption [ Time Frame: 4 month ]using a treadmill test and continues oxygen consumption measurement
- Muscle strength and mass [ Time Frame: 4 month ]muscle strength: hand grip test
|Study Start Date:||September 2010|
|Study Completion Date:||November 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01213784
|Dept. of cardiology, Aarhus university hospital Skejby|
|Aarhus, Region Midtjylland, Denmark, 8200|
|Principal Investigator:||Roni R Nielsen, MD||Dept. of cardiology, University hospital Aarhus Skejby|