HYPOglycemia Linked to Cardiac sTEatoSIS? - Identifying Mechanisms That Explain Adverse Cardiovascular Outcome Associated With Intensive Glucose Control in Patients With Diabetes (HYPOTESIS)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- MYCL
研究概览
简要总结
There is evidence that inhibition of FFA-release by acipimox is associated with a significant decrease in myocardial lipid content (MYCL) as well as the ejection fraction (as a marker of systolic left ventricular function) in healthy subjects, indicating, that the heart is dependent on a constant supply of free fatty acids in order to guarantee normal cardiac function, and it further indicates, that the heart is not able to cover its energy demand by switching to glucose oxidation.
Since that phenomenon, better known as "metabolic inflexibility" has been mainly described in patients with diabetes, we aim to investigate the impact of FFA-inhibition on MYCL and cardiac function in patients with overt type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Type 2 Diabetes
- •HbA1C >6%
排除标准
- •Insulin therapy (except: BOT=basal supported oral therapy)
- •Known heart disease including coronary artery disease, cardiomyopathy, history of cardiac surgery
- •Known intolerance against niacins
- •Known contra-indications against magnetic resonance (MR-) examinations
研究组 & 干预措施
acipimox+
250 mg at 0 and 180 minutes (one day)
干预措施: acipimox (Drug)
Placebo
1 Tablet at 0 and 180 minutes (one day)
干预措施: Placebo Oral Capsule (Drug)
结局指标
主要结局
MYCL
时间窗: 180 minutes
Intramyocardiocellular lipid content (MYCL) before and after administration of acipimox or placebo
次要结局
- Ejection Fraction(180 minutes)
研究者
Prof. Dr. Michael Krebs
Prof.MD
Medical University of Vienna