NCT05046483招募中不适用
Metabolic Phenotyping and Follow-Up of Patients With and Without Diabetes Mellitus After New Onset of ST-Segment Elevation Myocardial Infarction (STEMI) (DISTEMI Study)
German Diabetes Center1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2018年12月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Change of cardiac function
研究概览
简要总结
The aim of the prospective observational DISTEMI-Study in people with and without Diabetes mellitus (DI) after new onset of ST-Segment Elevation Myocardial Infarction (STEMI) aged 18-80 years at inclusion into the study is to characterize in detail the clinical, metabolical, immunological and vascular phenotype, investigate the interplay between myocardial remodelling and the metabolic phenotype, monitor the progression of the disease and compare the phenotype of STEMI people with diabetes mellitus to people with prediabetes and glucose tolerant people.
详细描述
In detail, the following questions will be answered:
- Do distinct metabolic phenotypes (with respect to insulin secretion, insulin sensitivity, circulating free fatty acids and ectopic lipid storage, especially in the liver) determine myocardial infarct size and decline of contractile function of the remote myocardium?
- Which factors modify the progression of the disease (insulin resistance, ectopic lipid storage, subclinical inflammation, abnormal energy metabolism)? People are thoroughly examined at baseline and one year after STEMI.
- Can we identify risk profiles and their relevance for development of diabetes-associated complications as well as long-term progression of diabetes?
- Can we improve risk assessment algorithms for targeted therapy in line with Precision Medicine?
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Condition after new onset of ST-segment elevation myocardial infarction (STEMI)
- •Age 18-80 years
- •HbA1c <9.0%
- •People with diagnosis of diabetes mellitus according to ADA and DDG criteria (i.e. HbA1c ≥6.5% and/or pathological oral glucose tolerance test)
- •Healthy people with normal glucose tolerance status according to ADA and DDG criteria (i.e. HbA1c <5.7% and normal OGTT)
- •People with impaired glucose metabolism ("prediabetes") according to ADA and DDG criteria (i.e. impaired fasting glucose and/or impaired glucose tolerance and/or HbA1c 5.7-6.4%)
- •Consent-able, hemodynamically stable people, without sedation (e.g. opiates) or other interfering medication (e.g. catecholamines)
排除标准
- •Diabetes mellitus category 3 A-H (ADA criteria), gestational diabetes
- •Current pregnancy
- •Infectious diseases, acute infections / fever
- •Immunosuppressive therapy
- •Severe chronic renal, liver or heart disease (e.g. serum creatinin ≥1.6 mg/dl, peripheral artery occlusive disease stage IV)
- •Malignant diseases
- •Severe chronic psychiatric illness or addiction
- •Participation in an intervention trial
结局指标
主要结局
Change of cardiac function
时间窗: One year
Measurement of left-ventricular ejection fraction by cardiac magnetic resonance (MR) imaging
次要结局
- Change of liver stiffness(One year)
- Incidence of further cardiovascular diseases (CVD) and STEMI-related complications, new onset of prediabetes and diabetes mellitus and associated comorbidities(One year)
- Change of insulin sensitivity (M-Value)(One year)
- Change of ectopic fat distribution(One year)
- Change of energy metabolism(One year)
- Change of mitochondrial respiratory function(One year)
- Change of Homeostasis Model Assessment 2 Estimate(One year)
- Change of insulin secretion(One year)
- Change of Fatty liver index(One year)
研究者
研究点 (1)
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