INTACT Trial - an Observational Study to Assess Neuropathy in Diabetic Children

Heim Pal Children's Hospital

Status: Not yet enrolling

Conditions: Diabetes Mellitus

Treatments: Diagnostic Test: uroflowmetry; Diagnostic Test: peripheral nerve conduction test; Diagnostic Test: Cardiovascular autonomic dysfunction test proposed by Ewing et al.

Study type: Observational

Funder types: Other

Identifiers

NCT05247840

KUT-37/2021

Details and patient eligibility

About

It is a prospective, cross-sectional, observational, controlled, single centre clinical study. Diabetic patients fulfilling the inclusion criteria and healthy controls will have uroflowmetry examination, cardiovascular autonomic dysfunction tests (heart rate response to deep breathing, to Valsalva maneuver, blood pressure and heart rate response to standing up, and to sustained handgrip), and peripheral nerve conduction test. The primary endpoint is the diagnostic accuracy (sensitivity, specificity, negative and positive predictive values) of the tests. The secondary endpoints are: differences in metabolic status (weight, height, body surface, BMI, laboratory parameters, body composition), fluid turnover, and clinical symptoms of diabetic patients comparing to healthy children.

Full 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 pressure values are recorded continuously. Heart rate response to deep inspiration is executed to investigate the parasympathetic nervous system. Peripheral neuropathy is evaluated by nerve conduction test.

The trial will start with a pilot period, when the first 50 diabetic and 50 healthy children will be assessed. This will be followed by a short evaluation period, during which the principal investigators and the study team could make adjustments in the study protocol to ensure feasibility.

Enrollment: 350 estimated patients

Sex: All

Ages: 5 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 5-18 years (boys, girls) with type 1, type 2 and monogenic DM

Exclusion criteria

1. Acute febrile condition (≥38 °C core temperature) in the past seven days

2. Acute or chronical urinary tract or kidney disease: renal insufficiency (GFR ≤ 60 mL/min per 1.73 m2, urinary tract infection

3. Urological disease: bladder cancer, urolithiasis, urethral stricture, posterior urethral valve, meatal stenosis, previous genitourinary surgery, conditions causing urinary outflow problems (phimosis, hypospadias, vesicoureteral reflux)

4. Cystic fibrosis-related diabetes (CFRD)

5. Neurological disorders (multiple sclerosis, transient ischaemic attack, transverse myelitis, myelocele, meningomyelocele, previous spinal cord operation, or operation which might injure the sacral nerve plexus)

6. Medicines taken which can cause neuropathy:

   1. Cytostatic agents: cyclophosphamide, platinum-based antineoplastic agents, vinca alkaloids, epothilones, taxanes, proteasome inhibitors, immunomodulatory drugs
   2. Immunosuppressive agents: TNF-alfa inhibitors (adalimumab, infliximab, etanercept), interferon
   3. Cardiovascular medicines: statins, digoxin, amiodaron
   4. Antimicrobial agents: nitrofurantoin, linezolid, voriconazole, itraconazole, antituberculotics, metronidazole, fluoroquinolone
   5. Anti-ulcerative agent: cimetidin
   6. Neuropsychological agents: levodopa, fenitoin

7. Psychiatric disorders that prevents participation / collaboration in the study

8. Constipation (defined according to the Rome IV criteria)

9. Voided volume <20 mL

10. Patients who are pregnant, or gave birth in the last 12 months

11. Lack of consent of the patient or legal representative; the patient or legal representative withdraws his or her voluntary consent during the study

Trial design

350 participants in 2 patient groups

diabetic children

Description:

Children aged 5-18 years (boys, girls) with type 1, type 2 and monogenic diabetes mellitus who are treated at the Endocrinology Department and Outpatient Clinic of Heim Pál National Pediatric Institute (HOGYI, Budapest, Hungary) will be enrolled. Definition of diabetes is based on the American Diabetes Association (ADA) criteria. All patients who meet the inclusion criteria will be informed of the possibility of taking part in the INTACT Trial.

Treatment:

Diagnostic Test: peripheral nerve conduction test

Diagnostic Test: uroflowmetry

Diagnostic Test: Cardiovascular autonomic dysfunction test proposed by Ewing et al.

healthy children

Description:

Healthy children aged 5-18 years (boys, girls) without any acute or chronical disease will be will enrolled and the same tests will be performed on them as in diabetic children. Children with voided volume \<20 mL, postvoid residual volume \>15%, and signs of an overstretched bladder \[voided volume more than: 30 x age (years) + 30 mL\] will be excluded.

Treatment:

Diagnostic Test: peripheral nerve conduction test

Diagnostic Test: uroflowmetry

Diagnostic Test: Cardiovascular autonomic dysfunction test proposed by Ewing et al.