Pilot Study for the Evaluation of the Effects of Insulin Treatment on Myocardial Function, Perfusion, and Glucose Metabolism in Patients With Primary Left Ventricular Dysfunction and Type 2 Diabetes.
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Sanofi
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- effect of insulin treatment on myocardial function, perfusion and glucose metabolism.
- Status
- Completed
- Last Updated
- 16 years ago
Overview
Brief Summary
The primary objective of the present study is to assess changes of myocardial glucose uptake (MGU) during clamp studies using positron emission tomography (PET) scanning in patients with type 2 diabetes and idiopathic left ventricular dysfunction (LVD).
The secondary objectives of the study are: assessment of changes of myocardial microcirculation at rest and during adenosine stimulation using PET; assessment of changes in myocardial structure and function evaluated by magnetic resonance imaging (MRI); assessment of glycaemic control by measurement of HbA1c, fasting blood glucose and insulin levels; assessment of safety (adverse event profile, laboratory data).
Investigators
Eligibility Criteria
Inclusion Criteria
- •LV systolic dysfunction (2D-Echo LVEF \< 50%) with or without LV dilation (2D-Echo LV EDD \> 56 mm) or left ventricular end-diastolic diameter (LVEDD) \>55mm with or without LV dysfunction
- •angiographically normal coronary arteries (\< 50% vessel narrowing);
- •newly diagnosed type 2 diabetes;
- •previously diagnosed: OAD treated type 2 diabetic patients able to take part in the study after a one-month wash-out period and insulin treated type 2 diabetic patients able to take part in the study after one week wash-out period.
Exclusion Criteria
- •evidence of congenital or valvular cardiac diseases, hypertrophic cardiomyopathy, overt heart failure (NYHA class III-IV);
- •moderate to severe hypertension (diastolic aortic pressure \> 100 mmHg);
- •hypotension (systolic aortic pressure \< 100 mmHg);
- •nephropathy (serum creatinine \> 3 mg/dL);
- •other systemic and/or infective diseases;
- •severe dyslipidemia;
- •peripheral vasculopathy;
- •necessity of vasoactive medical treatment in the last 48 hours;
- •atrial fibrillation;
- •Refusal or impossibility to give written informed consent;
Outcomes
Primary Outcomes
effect of insulin treatment on myocardial function, perfusion and glucose metabolism.
Time Frame: assessed before and after treatment
adverse events
Time Frame: throughout the study
Secondary Outcomes
- changes of myocardial structure and left ventricular systolic and diastolic function(at baseline and at the end of the study)