Metabolic Effects of Exogenous 3-hydroxybutyrate in Patients With Type 1 Diabetes and Healthy Controls
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Differences in lipolysis rate
研究概览
简要总结
The main objective of this clinical trial is to study the metabolic effects of intravenous infusion of the ketone body, 3-hydroxybutyrate (3-OHB), in patients with type 1 diabetes and healthy control subjects. Moreover, the investigators plan to examine regulatory mechanisms of 3-OHB that may be related to diabetic ketoacidosis.
The hypotheses are:
- 3-OHB related inhibition of lipolysis is impaired in patients with type 1 diabetes.
- Intravenous infusion of 3-OHB affects signaling pathways involved in the metabolic regulation in patients with type 1 diabetes and healthy controls.
- 3-OHB infusion improves cardiac function in patients with type 1 diabetes and healthy controls.
The effects of 3-OHB will be investigated by isotopic tracers examinations, fat and muscle biopsies and blood samples. To evaluate effects on cardiac function echocardiography will be performed.
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 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Patients with type 1 diabetes:
- •Inclusion Criteria:
- •Type 1 diabetes diagnosis
- •C-peptide negative
- •19 < BMI < 26
- •written consent
排除标准
- •Severe comorbidity
- •Regular medication apart from insulin (except over-the-counter medicines)
- •Use of long acting insulin analogues, that work > 24 hours, e.g. Tresiba
- •PI finds the patient not fit (e.g. mental illness, too nervous, unacceptable screening blood tests or other).
- •Healthy control subjects:
- •Inclusion Criteria:
- •19 < BMI < 26
- •written consent
- •Exclusion Criteria:
- •Chronic disease
- •Regular medication (except over-the-counter medicines)
- •PI finds the patient not fit (e.g. mental illness, too nervous, unacceptable screening blood tests or other).
研究组 & 干预措施
Control
3 hours of continuously intravenous infusion of saline (NaCl).
干预措施: 3-hydroxybutyrate (Biological)
Intervention
3 hours of continuously intravenous infusion of 3-hydroxybutyrate.
干预措施: 3-hydroxybutyrate (Biological)
结局指标
主要结局
Differences in lipolysis rate
时间窗: After 3 hours of interventions
Measured as differences in palmitate flux
次要结局
- Changes in protein metabolism(After 3 hours of interventions)
- Changes in glucose kinetics(After 3 hours of interventions)
- Cardiac function(After 2-3 hours of interventions)
- Changes in signaling in muscle and adipose tissue(After 1,5-3 hours of interventions)
- Differences in circulating concentrations of 3-hydroxybutyrate, glucose, free fatty acids, insulin, glucagon and C-peptide(During the 3 hours intervention period)