Status:
NOT_YET_RECRUITING
INTACT Trial - an Observational Study to Assess Neuropathy in Diabetic Children
Lead Sponsor:
Heim Pal Children's Hospital
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
5-18 years
Brief Summary
It is a prospective, cross-sectional, observational, controlled, single centre clinical study. Diabetic patients fulfilling the inclusion criteria and healthy controls will have uroflowmetry examinati...
Detailed Description
The autonomic nervous system function is examined by the reproducible and standardized cardiovascular reflex tests described by Ewing et al.. During the examination, electrocardiogram and blood pressu...
Eligibility Criteria
Inclusion
- 5-18 years (boys, girls) with type 1, type 2 and monogenic DM
Exclusion
- Acute febrile condition (≥38 °C core temperature) in the past seven days
- Acute or chronical urinary tract or kidney disease: renal insufficiency (GFR ≤ 60 mL/min per 1.73 m2, urinary tract infection
- Urological disease: bladder cancer, urolithiasis, urethral stricture, posterior urethral valve, meatal stenosis, previous genitourinary surgery, conditions causing urinary outflow problems (phimosis, hypospadias, vesicoureteral reflux)
- Cystic fibrosis-related diabetes (CFRD)
- Neurological disorders (multiple sclerosis, transient ischaemic attack, transverse myelitis, myelocele, meningomyelocele, previous spinal cord operation, or operation which might injure the sacral nerve plexus)
- Medicines taken which can cause neuropathy:
- Cytostatic agents: cyclophosphamide, platinum-based antineoplastic agents, vinca alkaloids, epothilones, taxanes, proteasome inhibitors, immunomodulatory drugs
- Immunosuppressive agents: TNF-alfa inhibitors (adalimumab, infliximab, etanercept), interferon
- Cardiovascular medicines: statins, digoxin, amiodaron
- Antimicrobial agents: nitrofurantoin, linezolid, voriconazole, itraconazole, antituberculotics, metronidazole, fluoroquinolone
- Anti-ulcerative agent: cimetidin
- Neuropsychological agents: levodopa, fenitoin
- Psychiatric disorders that prevents participation / collaboration in the study
- Constipation (defined according to the Rome IV criteria)
- Voided volume \<20 mL
- Patients who are pregnant, or gave birth in the last 12 months
- Lack of consent of the patient or legal representative; the patient or legal representative withdraws his or her voluntary consent during the study
Key Trial Info
Start Date :
September 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT05247840
Start Date
September 1 2022
End Date
September 1 2027
Last Update
August 5 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Heim Pal National Pediatric Institute
Budapest, Hungary, 1089