E10.91
Conditions
Interventions
Group 1: Children and adolescents with type 1 diabetes
Studyprocedure
First information and informed consent. During screening visit, data on sex, age, height, weight, body mass index, medical and fam
Sponsors
Kinder- und Jugendkrankenhaus AUF DER BULT
Eligibility
Sex/Gender
All
Age
12 Years to 18 Years
Inclusion criteria
Inclusion criteria: - T1D more than 5 years (only group A) - Age 12-18 years - No diabetic ketoacidosis in the last 6 months (only group A) - Written consent from at least one parent/guardian
Exclusion criteria
Exclusion criteria: - Known heart defects such as hemodynamically relevant ventricular or atrial septal defect, transposition of the great arteries, aortic isthmus stenosis, tetralogy of Fallot, hypoplastic left heart syndrome, Ebstein anomaly, double aortic arch - Pre-existing heart failure - Hypertrophic cardiomyopathy - Cardiac arrhythmias - Known arterial hypertension - Known renal insufficiency - Chronic pulmonary diseases: severe bronchial asthma, cystic fibrosis, pulmonary hypertension - A history of cancer - Pregnancy (clinical indication) - Diabetic ketoacidosis within the last 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the prevalence of pathological differences in cardiac function, in particular the UTR/twist in combination with the E/A ratio under sub-maximal exercise in children and adolescents with type 1 diabetes and its correlation with glycemic metrics (coefficient of variation [CV], Time in Range [TIR], Time below Range [TBR], Time above Range [TAR], average glucose [AV], standard deviation [SD]). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Association between HbA1c and cardiac-skeletal muscle interaction - Influence of maximum glucose values on relationship between cardiac output and skeletal muscle oxygen consumption - Influence of pre-exercise glucose levels on relationship between cardiac output and skeletal muscle oxygen consumption - Influence of minimum glucose values on relationship between cardiac output and skeletal muscle oxygen consumption - Influence of the rate of glucose change on relationship between cardiac output and skeletal muscle oxygen consumption - Influence of glycemic variability on muscle oxygen saturation - Evaluation of differences on relationship between cardiac output and skeletal muscle oxygen consumption between the sexes - Influence of BMI on relationship between cardiac output and skeletal muscle oxygen consumption - Association with positive history of diabetic ketoacidosis - Influence of lipid metabolism on relationship between cardiac output and skeletal muscle oxygen consumption - Influence of diabetes duration on relationship between cardiac output and skeletal muscle oxygen consumption - Evaluation of different lactate elevations between T1D and controls | — |
Countries
Germany
Contacts
Public ContactOlga Kordonouri
Kinder- und Jugendkrankenhaus AUF DER BULT
Outcome results
None listed