Type 2 Diabetes Clinical Trial
Official title:
Abnormal Glucose Tolerance is Associated With a Reduced Myocardial Metabolic Flexibility in Patients With Dilated Cardiomyopathy
Verified date | May 2015 |
Source | Azienda Ospedaliero, Universitaria Pisana |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Observational |
Dilated cardiomyopathy (DCM) is characterized by a metabolic shift from fat to carbohydrates and failure to increase myocardial glucose uptake in response to workload increments. The investigators aimed at verifying whether this pattern is influenced by the presence of abnormal glucose tolerance (AGT).
Status | Enrolling by invitation |
Enrollment | 15 |
Est. completion date | June 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years to 69 Years |
Eligibility |
Inclusion Criteria: For patients with dilated cardiomyopathy: - Myocardial left ventricular ejection fraction (LVEF) <40% - left ventricular end-diastolic diameter (LVEDD) >56 mm For patients without dilated cardiomyopathy: - LVEF >50% - LVEDD <56 mm. Exclusion Criteria: - NYHA class IV - Atrial fibrillation - Previous myocardial infarction - Valvular heart disease - Myocarditis - Pericarditis - Severe to moderate systemic arterial hypertension - Fasting hyperglycaemia (>7.0 mmol/l) - Treated diabetes, autoimmune diseases, neoplasia, kidney, liver or respiratory failure |
Observational Model: Case Control, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
Italy | Azienda Ospedaliero-Universitaria Pisana | Pisa | PI |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliero, Universitaria Pisana |
Italy,
Neglia D, De Caterina A, Marraccini P, Natali A, Ciardetti M, Vecoli C, Gastaldelli A, Ciociaro D, Pellegrini P, Testa R, Menichetti L, L'Abbate A, Stanley WC, Recchia FA. Impaired myocardial metabolic reserve and substrate selection flexibility during stress in patients with idiopathic dilated cardiomyopathy. Am J Physiol Heart Circ Physiol. 2007 Dec;293(6):H3270-8. Epub 2007 Oct 5. — View Citation
Stanley WC, Recchia FA, Lopaschuk GD. Myocardial substrate metabolism in the normal and failing heart. Physiol Rev. 2005 Jul;85(3):1093-129. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Myocardial metabolic responses to stress in humans | The investigators aimed at evaluating myocardial NEFA and glucose uptake. | Arterio-venous sampling will be performed in about an hour during three experimental condition: rest (time -15 and 0 min), pacing (3 and 6 min), and recovery (1, 5, 15 and 30 min). | No |
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