NCT05159570已完成不适用
Modulation of Circulating Levels of the Ketone Body 3-hydroxybutyrate in Patients With Type 2 Diabetes and Heart Failure With Preserved Ejection Fraction: Metabolic Effects.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Differences in lipolysis rate
研究概览
简要总结
Heart failure (HF) is among the most common causes of death in patients with type 2 diabetes (T2D). Ketones, 3-hydroxybutyrate (3-OHB), have shown to have beneficial effects in patients with hearth failure with reduced ejection fraction. However, this have never been investigated in patients with heart failure with preserved ejection fraction (HFpEF).
In this study we would like to investigate the effect of 14 days modulation of circulating ketone body levels on whole body and skeletal metabolism in patients with HFpEF and T2D.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(i) Type 2 diabetes, (ii) LVEF > 40 %, (iii) a clinical diagnosis of HFpEF and/or left ventricular hypertrophy (posterior wall thickness > 12 mm) and/or previous myocardial infarction, (iiii) age ≥ 18 years old, and (iv) one of the following criteria (a-d) should be fulfilled:
- •Echocardiographic signs of diastolic dysfunction E/e' > 8 Septal e ́< 7 cm/s and/or lateral e ́ < 10 cm/s Left atrium volume index ≥34 mL/m2 and/or left atrial diameter > 4 cm NT-proBNP > 125 pg/ml.
排除标准
- •Insulin treatment, inability to give informed consent
结局指标
主要结局
Differences in lipolysis rate
时间窗: After 14 days treatment
Measured as differences in palmitate flux
次要结局
- Changes in glucose kinetic(After 14 days treatment)
- Changes in signaling in muscle and adipose tissue(After 14 days treatment)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Modulation of Circulating Levels of the Ketone Body 3-hydroxybutyrate in Patients With Type 2 Diabetes and Heart Failure With Preserved Ejection Fraction: Cardiovascular Effects.Heart Failure With Preserved Ejection FractionKetonemiaDiabetes Mellitus, Type 2NCT05236335University of Aarhus24
已完成
2 期
Metabolic Effects of Chronic Ketosis (KETO-CHF Metabolic)Heart FailureNCT05161676University of Aarhus12
已完成
2 期
Hemodynamic Effects of Chronic Ketosis.Heart FailureNCT05161650University of Aarhus26
已完成
2 期
Hemodynamic Effects of Modulating Circulating Ketone Bodies With 1,3-butanediolHeart FailureNCT05768100Aarhus University Hospital12
已完成
不适用
The Effect of Liraglutide on Left Ventricular Function in Chronic Heart Failure Patients With and Without Type 2 Diabetes MellitusHyperglycemiaChronic Heart FailureNCT01472640Flyvbjerg, Allan, DMSc240