Myocardial Work and Left Ventricular Mechanical Dyssynchrony During Acute Changes in Plasma Glucose in Individuals With Type 1 Diabetes, Type 2 Diabetes and Without Diabetes
试验速览
- 阶段
- 不适用
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Change in the global work during hypoglycemia in individuals with type 1 diabetes, type 2 diabetes, and without diabetes, respectively.
研究概览
简要总结
Patients with diabetes have an increased risk of sudden cardiac death compared to the general population. Severe hypoglycemia is associated with an increased risk of cardiovascular (CV) disease (CVD) and events, including cardiac arrhythmias and sudden cardiac death; likewise, increased glycemic variability is associated with macrovascular complications and increased mortality. The physiological mechanisms linking hypoglycemia and glycemic variability to CVD and CV events remain unclear.
Myocardial work and mechanical dyssynchrony will be measured by speckle tracking echocardiography during euglycemia, hypoglycemia and hyperglycemia in individuals with type 1 diabetes, type 2 diabetes, and without diabetes. Echocardiographic images from three experimental clamp studies - Hypo-Heart 1 (sub-study 1), Hypo-Heart 2 (sub-study 2) and Rapid-Heart - will be included in this study.
详细描述
The results of this study may be compiled into one or more manuscripts for publication.
Study ID's:
Hypo-Heart 1 (sub-study 1): NCT03956173 Hypo-Heart 2 (sub-study 2): NCT03150030 Rapid-Heart: NCT04800536
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 (Investigator)
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
- •The present echocardiographic study includes 86 participants from three experimental clamp studies; the Hypo-Heart 1 (Study 1), Hypo-Heart 2 (Study 2) and Rapid-Heart (Study 3), including patients with type 1 diabetes (Hypo-Heart 1 and Rapid-Heart), patients with type 2 diabetes (Hypo-Heart 2) and healthy controls (Hypo-Heart 2).
- •Hypo-Heart 1:
- •Inclusion Criteria:
- •Informed and written consent
- •Type 1 diabetes diagnosed according to the criteria of the World Health Organization (WHO)
- •Age 18-70 years
- •Insulin treatment for ≥3 years
排除标准
- •Arrhythmia diagnosed prior to the screening visit
- •Implantable cardioverter defibrillator (ICD) or pacemaker at the time of inclusion
- •Severe heart failure (left ventricular ejection fraction <25%)
- •Structural heart disease (Wolf-Parkinson-White syndrome, congenital heart disease, severe valve disease)
- •Thyroid dysfunction (except for well-regulated eltroxin substituted myxoedema)
- •Anemia (male: hemoglobin <8.0; female: hemoglobin <7.0 mmol/l)
- •Hypo-Heart 2:
- •Inclusion Criteria: Patients with type 2 diabetes
- •Informed and written consent
- •Type 2 diabetes diagnosed according to the criteria of the World Health Organization (WHO)
- •Treatment with insulin
- •Glycated haemoglobin A1c (HbA1c) ≤58 mmol/mol
- •Inclusion Criteria: Healthy individuals
- •HbA1c ≤42 mmol/mol
- •Fasting plasma glucose ≤6.1 mmol/l
- •Exclusion Criteria: Patients with type 2 diabetes
- •Arrhythmia diagnosed prior to or at the time of inclusion
- •Implantable cardioverter defibrillator (ICD) or pacemaker at the time of inclusion
- •Severe heart failure (left ventricular ejection fraction <25%)
- •Structural heart disease (Wolf-Parkinson-White syndrome, congenital heart disease, severe valve disease)
- •Insulin naïve patients with type 2 diabetes
- •Thyroid dysfunction (except for well-regulated eltroxine substituted myxoedema)
- •Unable to comply with daily CGM during run-in period
- •Anemia (male: hemoglobin < 8.0; female: hemoglobin < 7.0 mmol/l)
- •Exclusion Criteria: Healthy individuals
- •Type 1 or type 2 diabetes
- •Prediabetes (HbA1c >42 mmol/l and/or fasting plasma glucose >6.1 mmol/l)
- •Family history of diabetes (type 1 og type 2 diabetes)
- •Arrhythmia diagnosed prior to or at the time of inclusion
- •ICD or pacemaker at the time of inclusion
- •Severe heart failure (left ventricular ejection fraction <25%)
- •Structural heart disease (Wolf-Parkinson-White syndrome, congenital heart disease, severe valve disease)
- •Thyroid dysfunction (except for well-regulated eltroxine substituted myxoedema)
- •Anemia (male: hemoglobin < 8.0; female: hemoglobin < 7.0 mmol/l)
- •Rapid-Heart:
- •Inclusion criteria - chronic hyperglycaemia cohort
- •Informed and written consent
- •Type 1 diabetes
- •Age ≥18 years
- •C-peptide negative (<0.2 nmol/l)
- •Insulin treatment for ≥1 year
- •HbA1C ≥63 mmol/mol
- •Inclusion criteria - well-controlled cohort
- •Informed and written consent
- •Type 1 diabetes
- •Age ≥18 years
- •C-peptide negative (<0.2nmol/l)
- •Insulin treatment for ≥1 year
- •HbA1C ≤53 mmol/mol
- •Exclusion criteria - both cohorts
- 另有 9 项未显示
研究组 & 干预措施
Cardiovascular effects of hypoglycemia in type 1 diabetes
干预措施: Hypoglycemia in type 1 diabetes (Other)
Cardiovascular effects of hypoglycemia in type 2 diabetes
干预措施: Hypoglycemia in type 2 diabetes (Other)
Cardiovascular effects of hypoglycemia in healthy controls
干预措施: Hypoglycemia in healthy controls (Other)
Cardiovascular effects of hyperglycemia in type 2 diabetes
干预措施: Hyperglycemia in type 2 diabetes (Other)
Cardiovascular effects of hyperglycemia in healthy controls
干预措施: Hyperglycemia in healthy controls (Other)
Cardiovascular effects of slowly declining plasma glucose in type 1 diabetes
干预措施: Hyperglycemia with slow decline in plasma glucose in type 1 diabetes (Other)
Cardiovascular effects of rapidly declining plasma glucose in type 1 diabetes
干预措施: Hyperglycemia with rapid decline in plasma glucose in type 1 diabetes (Other)
Cardiovascular effects of rebound hyperglycemia in type 1 diabetes
干预措施: Rebound hyperglycemia in type 1 diabetes (Other)
Cardiovascular effects of rebound euglycemia in type 1 diabetes
干预措施: Rebound euglycemia in type 1 diabetes (Other)
结局指标
主要结局
Change in the global work during hypoglycemia in individuals with type 1 diabetes, type 2 diabetes, and without diabetes, respectively.
时间窗: 255 minutes (Hypo-Heart 1) and 190 minutes (Hypo-Heart 2)
Absolute change in the global work index measured by pressure-strain loop analysis during insulin-induced hypoglycemia compared to euglycemia in individuals with type 1 diabetes, type 2 diabetes, and without diabetes, respectively (Hypo-Heart 1 and Hypo-Heart 2). Study outcomes will be analyzed separately for each included study.
次要结局
- Primary secondary outcome: Change in mechanical dyssynchrony during hypoglycemia in individuals with type 1 diabetes, type 2 diabetes, and without diabetes, respectively.(255 minutes (Hypo-Heart 1) and 190 minutes (Hypo-Heart 2))
- Change in the global work during recovery in individuals with type 1 diabetes.(255 minutes)
- Change in mechanical dyssynchrony during hyperglycemia in individuals with type 1 diabetes, type 2 diabetes and without diabetes, respectively.(255 minutes (Rapid Heart) and 190 minutes (Hypo-Heart 2))
- Change in the global work during hyperglycemia in individuals with type 1 diabetes, type 2 diabetes and without diabetes, respectively.(255 minutes (Rapid Heart) and 190 minutes (Hypo-Heart 2))
- Change in mechanical dyssynchrony during recovery in individuals with type 1 diabetes.(255 minutes)