NCT00335465已完成4 期
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.
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- effect of insulin treatment on myocardial function, perfusion and glucose metabolism.
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
- •patients diagnosed with type 1 insulin dependent diabetes;
- •clinically relevant cardiovascular, hepatic, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult;
- •patients with medical history positive for cerebrovascular accidents, including Transient Ischaemic Attack (TIA);
- •women who are lactating, pregnant, or planning to become pregnant during the study;
- •history of hypersensitivity to the investigational products or to drugs with similar chemical structures;
- •likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol;
- •treatment with any investigational product in the last 30 days or 5 half-lives (whichever is longer) before study entry;
- •current use of investigational agents or participation in any other investigational studies during study period;
- •history of drug or alcohol abuse;
- •impaired hepatic function, as shown by Alamine AminoTransferase (ALT) > 2,5 times the upper limit of the normal laboratory range;
- •mental condition making the subject unable to understand the nature, scope, and possible consequences of the study;
- •patients unable to understand dosing directions;
- •subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study procedures;
- •receipt of an experimental drug or use of an experimental device within the 30 days prior to study entry;
- •previous enrollment in the present study.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
effect of insulin treatment on myocardial function, perfusion and glucose metabolism.
时间窗: assessed before and after treatment
adverse events
时间窗: throughout the study
次要结局
- changes of myocardial structure and left ventricular systolic and diastolic function(at baseline and at the end of the study)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
The Set-Point Study: Evaluating Effects of Changing Glucose Target on Bionic Pancreas PerformanceType 1 DiabetesType 2 DiabetesNCT02509065Massachusetts General Hospital24
已完成
不适用
The Effect and Safety of a Novel CGM-Based Titration Algorithm for Basal Insulin in T2DM Participants.Type 2 DiabetesNCT06111508University of Virginia30
已完成
不适用
Cleaner Air for Lower Cardiometabolic RiskPreDiabetesNCT05994937NYU Langone Health150
已完成
1 期
Study of the Acute Metabolic Effect of Exenatide in Type 1 DiabetesType 1 DiabetesNCT01855490Yale University17
已完成
不适用
The Primary Objective of This Study Was to Investigate the Effect of Insulin on Myocardial Perfusion and Cardiac Function in Patients Undergoing Cardiac Surgery for CPB Using Transesophageal Echocardiography (TEE) to Detect CSBFInsulinNCT05464966Yangzhou University74