NCT01213784CompletedPhase 2
Optimized Glycemic Control in Type 2 Diabetics With Heart Failure:"Effect on Left Ventricular Function and Skeletal Muscle"
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Aarhus
- 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
Study Sites (2)
Loading locations...
Similar Trials
Not yet recruiting
Not Applicable
Effect the Glycemic Control on Cardiac FunctionCardiac FunctionGlycemic ControlNCT06761820Assiut University200
Completed
Not Applicable
How Improvement in Control of Diabetes Influences the Production of a Hormone Produced in the Gut Which Improves the Release and Action of Insulin.Type 2 Diabetes MellitusNCT00747383The Royal Bournemouth Hospital74
Completed
Not Applicable
DARE: Diabetes in cArdiac REhabilitationType 2 Diabetes MellitusCoronary Artery DiseaseNCT00354237Centre Hospitalier Universitaire Dijon60
Unknown
Not Applicable
Can Enhanced Glycemic Control in Type II Diabetics Improve Myocardial Protection During Coronary Artery Bypass Grafting?Type 2 DiabetesNCT00899483University Hospital Birmingham100
Completed
Phase 3
A Study to Evaluate Combining Metformin With Muraglitazar or Pioglitazone in Type 2 DiabeticsType 2 DiabetesNCT00240370Bristol-Myers Squibb1,159