Insulin Resistance Clinical Trial
Official title:
Cardioprotective and Metabolic Effects of Metformin in Patients With Heart Failure and Diabetes
The aim of the study is to evaluate the effect of metformin on myocardial function, insulin
resistance and selected metabolic markers in patients with type 2 diabetes and heart failure
(HF+DM+) in a cross-over, randomized, placebo controlled trial.
Hypothesis:
Metformin treatment in HF+DM+ group will lead to better myocardial function and load
tolerance in comparison to placebo. The degree of improvement will be linked to selected
metabolic parameters.
40 patients with HF and DM without previous diabetes treatment will be randomized into 2 groups (A succession: MET-placebo, B succession: placebo-MET) - stratified randomization with following parameters weighted: HF etiology (ischemic /non-ischemic), diabetes duration, gender, BMI, age, NYHA, smoker/non-smoker). After 3 months the treatment will be switched. All participants will undergo standardized selection of metabolic and cardiovascular tests (hyperinsulinemic euglycemic clamp with indirect calorimetry, measurement of endothelial function, echocardiography, spiroergometry, proton/phosphor MR spectroscopy, adipose tissue biopsy, selected cytokines in plasma and adipose tissue at the beginning and the end of each intervention period (3 times in total). ;
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