type 2 diabetes mellitus, heart failure
Conditions
Interventions
Trade Name: Siofor 1000 potahované tbl
Product Name: Siofor 1000 potahované tbl
Product Code: 0018630
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Each 1000 mg film-coated tablet contains
Sponsors
Institute for Clinical and Experimental Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.chronic heart failure will be defined by the following criteria (all must be included): ?diagnosis of HF known for at least 6 months ?medical history of hospitalization for cardiac decompensation with need for parenteral therapy for congestion - X-ray findings or swelling of lower extremities ?stable drug therapy at least 1 month ?treatment with diuretics (thiazide or furosemide) ?LVEF below 50% 2.the presence of diabetes will be defined by: ?diagnosis and treatment of type 2 diabetes in the medical history ?screening blood sample: ¦the value of HbA1c(according to IFCC)= 4.8% + fasting glucose = 7.0 mmol / l in venous plasma or ¦the value of HbA1c = 4.8%(according to IFCC) + random blood glucose = 11.1 mmol/l in venous plasma ¦or OGTT - blood glucose level at 120 min = 11.1 mmol/l OGTT is indicated just in case of positivity of one of the criteria (fasting glucose + HbA1c or HbA1c + random blood glucose) 3.treatment of diabetes - by diet only 4.women and men aged 40-70 years 5.body mass index (kg/m2) in the range of 20-35 6.the range of HbA1c between 4-6,5% IFCC 7.signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1.the planned cardiac intervention during the study that affect the function of the heart (revascularization including PCI, heart surgery, implantation of pacemaker, RF ablation; urgent candidate for OTS 2.metabolic disease, including: 1 type diabetes, decompensated thyreopatii (Note: patients with hypothyroidism and stable substitution (the last 3 months) of normal TSH levels may participate in the study 3.treatment with insulin or PAD one month before the recruitment(patients who were temporarily treated with insulin during hospitalization may participate in the study) 4.pregnancy (positive ß-HCG test), breast feeding, trying to become pregnant 5.clinically significant anemia with hemoglobin below 100 g/l 6.pacemaker or metallic implant in the body (MRI) 7.renal insufficiency with eGF below 0.7 ml/s 8.atrial fibrillation - present during screening test 9.the presence of other medical condition, which occurs during physical examination, laboratory tests, ECG, including pulmonary, neurological or inflammatory disease, which would be considered by the examiner to distort the consistency of data
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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+) ;Secondary Objective: to evaluate the effect of metformin on energy expenditure, endothelial function, echocardiography, spiroergometry, proton/phosphor MR spectroscopy, endocrine activity of adipose tissue (biopsy), selected cytokines in plasma and adipose tissue ;Primary end point(s): 1/Provide causal link between IR and exercise intolerance in HF 2/Improvement of chronotropic response (chronotropy index during ergometry) 3/Improvement of diastolic function 4/Improvement of cardiac energetic reserve (MRI, resting Phospho Creatine/Creatine ratio) 5/Improvement of ventriculo-vascular coupling 6/Improvement of endothelial function (Endo-PAT, ItamarMedical);Timepoint(s) of evaluation of this end point: no | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1/humoral determinants of insulin resitance in HF correlation with leptin, TNF alfa, norepinephrine, glucagon, adiponectin 2/to determine whether profile of effects of MET is influenced by presence of HF state;Timepoint(s) of evaluation of this end point: no | — |
Countries
Czech Republic
Contacts
Public ContactDiabetes Center
Institute for Clinical and Experimental Medicine
Outcome results
None listed