Cardiovascular Effects of Exercise-related Hypoglycaemia in Patients With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Hypoglycaemia and QTc interval prolongation
研究概览
简要总结
Patients with type 1 diabetes are recommended to perform at least 150 minutes of accumulated physical activity each week, however fear of hypoglycaemia is a well-known barrier to exercise in these patients. Previous experimental studies have almost exclusively focused on investigating cardiovascular effects of hypoglycaemia under resting conditions, however other underlying circumstances prior to or during a hypoglycaemic event, (e.g. exercise) are rarely discussed in the literature but might, nevertheless, be of significant clinical importance.
In this study, the investigators aim to investigate the QT interval dynamics and prothrombotic factors during exercise-related hypoglycaemia in comparison with hypoglycaemia under resting conditions, in patients with type 1 diabetes.
Fifteen patients with type 1 diabetes will be recruited for a crossover study including two test days, a combined euglycaemic- hypoglycaemic clamp combined with an exercise session and an euglycaemic- hypoglycaemic clamp during bed rest, respectively. Furthermore, the participants will be schedueled for a 24-hours followup visit after each test day for the purpose of investigating prolonged prothrombotic effects of hypoglycaemia. Patients will be randomised 1:1 to start with the combined exercise-clamp or the resting-clamp. The two test days will be separated by at least 4 weeks to minimise carry-over effects. A group of fifteen healthy individuals with normal glucose tolerance matched for age, gender and body mass index, will be recruited for a single blood test aiming to compare baseline coagulation status with patients with type 1 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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Informed and written consent
- •Type 1 diabetes diagnosed according to the criteria of the World Health Organization (WHO)
- •Age ≥ 18 years
- •Insulin treatment for ≥1 year
排除标准
- •Arrhythmia diagnosed prior to the screening visit.
- •Ischaemic heart disease or myocardial infarction diagnosed prior to the screening visit.
- •Implantable cardioverter defibrillator (ICD) or pacemaker at the time of inclusion
- •Heart failure (left ventricular ejection fraction <45%) diagnosed prior to the screening visit.
- •Structural heart disease (Wolf-Parkinson-White syndrome, congenital heart disease, severe valve disease)
- •ECG with left or right bundle branch block diagnosed prior to the screening visit.
- •Thyroid dysfunction (except for well-regulated levothyroxine-substituted myxoedema)
- •Anaemia (male: haemoglobin <8.0; female: haemoglobin <7.0 mmol/l)
- •Treatment with anticoagulant or antiplatelet treatment.
- •Bleeding disorder diagnosed prior to the screening visit.
- •Withdrawal criteria
- •The participants may withdraw at will at any time
结局指标
主要结局
Hypoglycaemia and QTc interval prolongation
时间窗: 0-180minutes
Mean QTc interval prolongation from baseline during exercise-related hypoglycaemia compared to insulin-induced hypoglycaemia under resting conditions.
次要结局
- Hypoglycaemia and QT dispersion (QTd)(0-180minutes)
- Key secondary outcome: Hypoglycaemia and coagulation and fibrinolysis(0-24hours)
- Hypoglycaemia and ectopic beats(0-180minutes)
- Hypoglycaemia and vascular oxidative stress(0-24hours)
- Hypoglycaemia and electrolytes(0-180minutes)
- Hypoglycaemia and inflammation(0-24hours)
- Hypoglycaemia and bradycardia(0-180minutes)
- Hypoglycaemia and counterregulatory hormonal response(0-180minutes)
- Hypoglycaemia and markers of inflammation(0-24hours)
- Type 1 diabetes, healthy controls and coagulability(0minutes)
- Hypoglycaemia and heart rate variability (HRV)(0-180minutes)
- Hypoglycaemia and endothelial activation and damage(0-24hours)
- Hypoglycaemia and continuous glucose monitoring (CGM) accuracy(0-180min)
研究者
Tina Vilsbøll
Professor
Steno Diabetes Center Copenhagen