Acute Changes in Plasma Glucose and Cardiovascular Disease in Diabetes (NCT05500352) | Clinical Trial Compass
UnknownNot Applicable
Acute Changes in Plasma Glucose and Cardiovascular Disease in Diabetes
Denmark86 participantsStarted 2022-07-01
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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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
Exclusion Criteria:
* 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
…
What they're measuring
1
Change in the global work during hypoglycemia in individuals with type 1 diabetes, type 2 diabetes, and without diabetes, respectively.
Timeframe: 255 minutes (Hypo-Heart 1) and 190 minutes (Hypo-Heart 2)