E10
Conditions
Interventions
Group 1: Single execution of testing on patients with Type I Diabetes
Group 2: Single execution of testing on healthy children
Sponsors
Universitätskinderklinik im St. Josef Hospital der Ruhr-Universität Bochum
Eligibility
Sex/Gender
All
Age
9 Years to 18 Years
Inclusion criteria
Inclusion criteria: children and adolescents with diabetes mellitus type 1 from the time of manifestation and healthy children and adolescents from 9 to 18 years
Exclusion criteria
Exclusion criteria: Patients are excluded who - do not consent to participate in the study, or their legal guardians do not consent, - are younger than 9 years or older than 18 years, - are incapable of informing for linguistic, psychological or somatic reasons, or are unable to participate in the CCM, PCES-EP, NLG or the QST examination, - have a syndromal disease - have a congenital metabolic disorder, - are substance abusers, - are pregnant, - have contraindications to individual investigations such as QST or Pain Evoked Potentials: - QST - Skin diseases in the area of examination - Local treatment in the area of examination with topical local anaesthetics (= 7 days in the last 6 weeks or = 7 days in the last 4 months) or with capsaicin (in the last 6 months). - marked hypersensitivity/allodynia - PCES-EP - Cardiac pacemaker - CCM - Eye surgery with conjunctival or corneal involvement or corneal injury within the last 3 months - Eye tremor (nystagmus) - Allergy to local anaesthetic Additional exclusion criteria for healthy subjects: - if there is a chronic internal, neurological or psychiatric disease, - currently taking medication (except contraceptives), - the average pain intensity in the last 4 weeks > 2 (NRS 0-10), - the current pain intensity is > 0 (NRS 0-10)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Type and frequency of abnormalities in the methods (QST, NLG, CCM) in a single measurement compared to healthy participants. | — |
Secondary
| Measure | Time frame |
|---|---|
| Relationship between pathological measurement results (QST, NLG, CCM) and laboratory parameters (Hb, HbA1c, cholesterol, triglycerides, LDL, HDL, creatinine, homocysteine, TSH, urinary microalbumin), duration of illness, age, cigarette smoking, blood pressure, weight, BMI, type of Insulin therapy | — |
Countries
Germany
Contacts
Public ContactLynn Eitner
Universitätskinderklinik im St. Josef Hospital der Ruhr-Universität Bochum
Outcome results
None listed