Diabetic polyneuropathy in Children - procedures for early detection and risk factors

Recruiting

• Conditions: E10; Type 1 diabetes mellitus

• Registration Number: DRKS00024565
• Lead Sponsor: niversitätskinderklinik im St. Josef Hospital der Ruhr-Universität Bochum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 180

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

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)

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Type and frequency of abnormalities in the methods (QST, NLG, CCM) in a single measurement compared to healthy participants.

Secondary Outcome Measures

Name	Time	Method
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