CARMETEfectos Cardioprotectores y Metabólicos de la Metformina en Pacientes con Insuficiencia Cardíaca y Diabetes
Este estudio tiene como objetivo evaluar los efectos cardioprotectores y metabólicos de la Metformina, específicamente su impacto en la sensibilidad a la insulina, en pacientes que viven con insuficiencia cardíaca e diabetes.
Metformini hydrochloridum (Siofor 1000 tbl, Berlin)
+ placebo
+ Metformini hydrochloridum (Siofor 1000 tbl, Berlin)
Diabetes Mellitus+4
+ Enfermedades del Sistema Endocrino
+ Hiperinsulinismo
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de noviembre de 2012
Fecha en la que se inscribió al primer participante.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).
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 40 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 40 a 70 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: 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% 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) treatment of diabetes - by diet only women and men aged 40-70 years body mass index (kg/m2) in the range of 20-35 the range of HbA1c between 4-6,5% IFCC signed informed consent Exclusion Criteria: 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 metabolic disease, including: 1 type diabetes, decompensated thyreopathy (Note: patients with hypothyroidism and stable substitution (the last 3 months) of normal TSH levels may participate in the study treatment with insulin or PAD one month before the recruitment(patients who were temporarily treated with insulin during hospitalization may participate in the study) pregnancy (positive β-HCG test), breast feeding, trying to become pregnant clinically significant anemia with hemoglobin below 100 g/l renal insufficiency with eGF below 0.7 ml/s atrial fibrillation - present during screening test 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
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
50% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
PlaceboObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Diabetes Center, Institute of Clinical and Experimental Medicine
Prague, CzechiaAbrir Diabetes Center, Institute of Clinical and Experimental Medicine en Google Maps