Status:
COMPLETED
Cardiovascular Effects of Rapidly Declining Plasma Glucose in Patients With Type 1 Diabetes
Lead Sponsor:
Steno Diabetes Center Copenhagen
Collaborating Sponsors:
University Hospital, Gentofte, Copenhagen
Rigshospitalet, Denmark
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Type 1 diabetes (T1D) is an autoimmune metabolic disease characterised by impaired lack of endogenous insulin causing elevated plasma glucose levels and increased risk of microvascular and macrovascul...
Eligibility Criteria
Inclusion
- 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
- Arrhythmia diagnosed prior to or at the time of the screening visit
- ECG with left or right bundle branch block diagnosed prior to the screening visit.
- Implantable cardioverter defibrillator or pacemaker at the time of inclusion
- Heart failure diagnosed prior to the screening visit (left ventricular ejection fraction \< 45%)
- Structural heart disease (Wolf-Parkinson-White syndrome, congenital heart disease, severe valve disease)
- Thyroid dysfunction (except for well-regulated myxoedema)
- Anaemia (male: haemoglobin \<8.0 mmol/l; 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
Exclusion
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04800536
Start Date
June 1 2021
End Date
April 1 2023
Last Update
April 12 2024
Active Locations (1)
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1
Steno Diabetes Center Copenhagen - Gentofte Hospital
Copenhagen, Denmark, 2900