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NCT Number: NCT05247840

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

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Heim Pal National Pediatric Institute

Budapest, 1089, Hungary

Location contact

László Szabó

PRINCIPAL_INVESTIGATOR

Martonosi

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

uroflowmetry

Diagnostic Test

Uroflowmetry will be performed using a uroflow-cystometer (UroDoc Frytech) which determines Qmax, Qave and TQmax. Voided volume (in mL), voiding time (in sec), average and maximum urinary flow rate (Qave and Qmax in mL/sec), and time to maximum urinary flow (TQmax in sec) will be measured; urine flow acceleration (Qacc in mL/sec2) will be calculated. Qmax and Qave are defined according to the International Children's Continence Society. Voided volume will be measured by the uroflow-cystometer device; boys void in a standing, girls in a sitting position. Postvoid bladder diameter (mm) will be measured by ultrasonography and converted to bladder residual volume (mL). The device will be calibrated according to the prescribed instructions for use by a skilled technician. The examinations will take approximately 10 minutes.

Other names: non-invasive urodynamic test

Cardiovascular autonomic dysfunction test proposed by Ewing et al.

Diagnostic Test

CAD will be assessed by five reproducible and standardized cardiovascular reflex tests described by Ewing et al. Three of the five tests assess parasympathetic function: heart rate response to deep breathing, to standing, and the Valsalva maneuver. Two tests evaluate sympathetic function which are blood pressure responses from lying to standing and at sustained handgrip. Each of these five tests is assigned a score of 0 for normal, 0.5 for borderline, and 1 for abnormal results. The sum of these 5 scores - which is the Ewing score - is used to assess severity of CAD. Patients having Ewing score ≥ 2 form the CAD + group, and patients who have less than 2 form the CAD - group.

peripheral nerve conduction test

Diagnostic Test

Peripheral neuropathy will be evaluated by nerve conduction test. The device measures motor conduction in the lower extremities. It operates at two dedicated frequencies in order to perform a thick myelin sheath cordless fibre (5Hz) and thin myelinated nerve fibre (2000Hz) examination. The device will be calibrated according to the prescribed instructions for use by a skilled technician.

Primary outcomes

  1. diagnostic accuracy of uroflowmetry test 1.1

    Time frame: baseline

    sensitivity, specificity, positive predictive value, negative predictive value

  2. diagnostic accuracy of uroflowmetry test 1.2

    Time frame: change from baseline at 12 months

    sensitivity, specificity, positive predictive value, negative predictive value

  3. diagnostic accuracy of uroflowmetry test 1.3

    Time frame: change from baseline at 24 months

    sensitivity, specificity, positive predictive value, negative predictive value

  4. diagnostic accuracy of uroflowmetry test 1.4

    Time frame: change from baseline at 36 months

    sensitivity, specificity, positive predictive value, negative predictive value

  5. diagnostic accuracy of uroflowmetry test 1.5

    Time frame: change from baseline at 48 months

    sensitivity, specificity, positive predictive value, negative predictive value

  6. diagnostic accuracy of uroflowmetry test 1.6

    Time frame: change from baseline at 60 months

    sensitivity, specificity, positive predictive value, negative predictive value

  7. diagnostic accuracy of cardiovascular autonomic dysfunction test 2.1

    Time frame: baseline

    sensitivity, specificity, positive predictive value, negative predictive value

  8. diagnostic accuracy of cardiovascular autonomic dysfunction test 2.2

    Time frame: change from baseline at 12 months

    sensitivity, specificity, positive predictive value, negative predictive value

  9. diagnostic accuracy of cardiovascular autonomic dysfunction test 2.3

    Time frame: change from baseline at 24 months

    sensitivity, specificity, positive predictive value, negative predictive value

  10. diagnostic accuracy of cardiovascular autonomic dysfunction test 2.4

    Time frame: change from baseline at 36 months

    sensitivity, specificity, positive predictive value, negative predictive value

  11. diagnostic accuracy of cardiovascular autonomic dysfunction test 2.5

    Time frame: change from baseline at 48 months

    sensitivity, specificity, positive predictive value, negative predictive value

  12. diagnostic accuracy of cardiovascular autonomic dysfunction test 2.6

    Time frame: change from baseline at 60 months

    sensitivity, specificity, positive predictive value, negative predictive value

  13. diagnostic accuracy of peripheral nerve conduction test 3.1

    Time frame: baseline

    sensitivity, specificity, positive predictive value, negative predictive value

  14. diagnostic accuracy of peripheral nerve conduction test 3.2

    Time frame: change from baseline at 12 months

    sensitivity, specificity, positive predictive value, negative predictive value

  15. diagnostic accuracy of peripheral nerve conduction test 3.3

    Time frame: change from baseline at 24 months

    sensitivity, specificity, positive predictive value, negative predictive value

  16. diagnostic accuracy of peripheral nerve conduction test 3.4

    Time frame: change from baseline at 36 months

    sensitivity, specificity, positive predictive value, negative predictive value

  17. diagnostic accuracy of peripheral nerve conduction test 3.5

    Time frame: change from baseline at 48 months

    sensitivity, specificity, positive predictive value, negative predictive value

  18. diagnostic accuracy of peripheral nerve conduction test 3.6

    Time frame: change from baseline at 60 months

    sensitivity, specificity, positive predictive value, negative predictive value

Secondary outcomes

  1. metabolic status 1.1

    Time frame: baseline

    weight (kg)

  2. metabolic status 1.2

    Time frame: change from baseline at 12 months

    weight (kg)

  3. metabolic status 1.3

    Time frame: change from baseline at 24 months

    weight (kg)

  4. metabolic status 1.4

    Time frame: change from baseline at 36 months

    weight (kg)

  5. metabolic status 1.5

    Time frame: change from baseline at 48 months

    weight (kg)

  6. metabolic status 1.6

    Time frame: change from baseline at 60 months

    weight (kg)

  7. metabolic status 2.1

    Time frame: baseline

    height (cm)

  8. metabolic status 2.2

    Time frame: change from baseline at 12 months

    height (cm)

  9. metabolic status 2.3

    Time frame: change from baseline at 24 months

    height (cm)

  10. metabolic status 2.4

    Time frame: change from baseline at 36 months

    height (cm)

  11. metabolic status 2.5

    Time frame: change from baseline at 48 months

    height (cm)

  12. metabolic status 2.6

    Time frame: change from baseline at 60 months

    height (cm)

  13. metabolic status 3.1

    Time frame: baseline

    body surface (m2 calculated by the Mosteller formula)

  14. metabolic status 3.2

    Time frame: change from baseline at 12 months

    body surface (m2 calculated by the Mosteller formula)

  15. metabolic status 3.3

    Time frame: change from baseline at 24 months

    body surface (m2 calculated by the Mosteller formula)

  16. metabolic status 3.4

    Time frame: change from baseline at 36 months

    body surface (m2 calculated by the Mosteller formula)

  17. metabolic status 3.5

    Time frame: change from baseline at 48 months

    body surface (m2 calculated by the Mosteller formula)

  18. metabolic status 3.6

    Time frame: change from baseline at 60 months

    body surface (m2 calculated by the Mosteller formula)

  19. metabolic status 4.1

    Time frame: baseline

    BMI (kg/m2)

  20. metabolic status 4.2

    Time frame: change from baseline at 12 months

    BMI (kg/m2)

  21. metabolic status 4.3

    Time frame: change from baseline at 24 months

    BMI (kg/m2)

  22. metabolic status 4.4

    Time frame: change from baseline at 36 months

    BMI (kg/m2)

  23. metabolic status 4.5

    Time frame: change from baseline at 48 months

    BMI (kg/m2)

  24. metabolic status 4.6

    Time frame: change from baseline at 60 months

    BMI (kg/m2)

  25. metabolic status 5.1

    Time frame: baseline

    body composition evaluated by the Inbody device

  26. metabolic status 5.2

    Time frame: change from baseline at 12 months

    body composition evaluated by the Inbody device

  27. metabolic status 5.3

    Time frame: change from baseline at 24 months

    body composition evaluated by the Inbody device

  28. metabolic status 5.4

    Time frame: change from baseline at 36 months

    body composition evaluated by the Inbody device

  29. metabolic status 5.5

    Time frame: change from baseline at 48 months

    body composition evaluated by the Inbody device

  30. metabolic status 5.6

    Time frame: change from baseline at 60 months

    body composition evaluated by the Inbody device

  31. metabolic status 6.1

    Time frame: baseline

    laboratory parameters (CRP, ESR, full blood count, Hemoglobin, hematocrit, thrombocyte, glucose, C-peptide, HbA1c, triglyceride, cholesterol, uric acid, creatinine, carbamide, AST, ALT, GGT, LDH, ALP, Na, K, P, Ca, albumin, serum total protein, lipase, amylase, urine rapid test)

  32. metabolic status 6.2

    Time frame: change from baseline at 12 months

    laboratory parameters (CRP, ESR, full blood count, Hemoglobin, hematocrit, thrombocyte, glucose, C-peptide, HbA1c, triglyceride, cholesterol, uric acid, creatinine, carbamide, AST, ALT, GGT, LDH, ALP, Na, K, P, Ca, albumin, serum total protein, lipase, amylase, urine rapid test)

  33. metabolic status 6.3

    Time frame: change from baseline at 24 months

    laboratory parameters (CRP, ESR, full blood count, Hemoglobin, hematocrit, thrombocyte, glucose, C-peptide, HbA1c, triglyceride, cholesterol, uric acid, creatinine, carbamide, AST, ALT, GGT, LDH, ALP, Na, K, P, Ca, albumin, serum total protein, lipase, amylase, urine rapid test)

  34. metabolic status 6.4

    Time frame: change from baseline at 36 months

    laboratory parameters (CRP, ESR, full blood count, Hemoglobin, hematocrit, thrombocyte, glucose, C-peptide, HbA1c, triglyceride, cholesterol, uric acid, creatinine, carbamide, AST, ALT, GGT, LDH, ALP, Na, K, P, Ca, albumin, serum total protein, lipase, amylase, urine rapid test)

  35. metabolic status 6.5

    Time frame: change from baseline at 48 months

    laboratory parameters (CRP, ESR, full blood count, Hemoglobin, hematocrit, thrombocyte, glucose, C-peptide, HbA1c, triglyceride, cholesterol, uric acid, creatinine, carbamide, AST, ALT, GGT, LDH, ALP, Na, K, P, Ca, albumin, serum total protein, lipase, amylase, urine rapid test)

  36. metabolic status 6.6

    Time frame: change from baseline at 60 months

    laboratory parameters (CRP, ESR, full blood count, Hemoglobin, hematocrit, thrombocyte, glucose, C-peptide, HbA1c, triglyceride, cholesterol, uric acid, creatinine, carbamide, AST, ALT, GGT, LDH, ALP, Na, K, P, Ca, albumin, serum total protein, lipase, amylase, urine rapid test)

  37. metabolic status 7.1

    Time frame: baseline

    fluid turnover in 24 hours (mL)

  38. metabolic status 7.2

    Time frame: change from baseline at 12 months

    fluid turnover in 24 hours (mL)

  39. metabolic status 7.3

    Time frame: change from baseline at 24 months

    fluid turnover in 24 hours (mL)

  40. metabolic status 7.4

    Time frame: change from baseline at 36 months

    fluid turnover in 24 hours (mL)

  41. metabolic status 7.5

    Time frame: change from baseline at 48 months

    fluid turnover in 24 hours (mL)

  42. metabolic status 7.6

    Time frame: change from baseline at 60 months

    fluid turnover in 24 hours (mL)

  43. clinical symptoms of diabetic patients will be measured and compared to healthy children. 8.1

    Time frame: baseline

    clinical symptoms (Urgent urination, Daily urine incontinence, Urination during night time, Nocturia, Frequency of bowel movement, Consistency of the stool)

  44. clinical symptoms of diabetic patients will be measured and compared to healthy children. 8.2

    Time frame: change from baseline at 12 months

    clinical symptoms (Urgent urination, Daily urine incontinence, Urination during night time, Nocturia, Frequency of bowel movement, Consistency of the stool)

  45. clinical symptoms of diabetic patients will be measured and compared to healthy children. 8.3

    Time frame: change from baseline at 24 months

    clinical symptoms (Urgent urination, Daily urine incontinence, Urination during night time, Nocturia, Frequency of bowel movement, Consistency of the stool)

  46. clinical symptoms of diabetic patients will be measured and compared to healthy children. 8.4

    Time frame: change from baseline at 36 months

    clinical symptoms (Urgent urination, Daily urine incontinence, Urination during night time, Nocturia, Frequency of bowel movement, Consistency of the stool)

  47. clinical symptoms of diabetic patients will be measured and compared to healthy children. 8.5

    Time frame: change from baseline at 48 months

    clinical symptoms (Urgent urination, Daily urine incontinence, Urination during night time, Nocturia, Frequency of bowel movement, Consistency of the stool)

  48. clinical symptoms of diabetic patients will be measured and compared to healthy children. 8.6

    Time frame: change from baseline at 60 months

    clinical symptoms (Urgent urination, Daily urine incontinence, Urination during night time, Nocturia, Frequency of bowel movement, Consistency of the stool)

Study contacts

Contact information is provided by the study sponsor or research team.

Martonosi

CONTACT

[email protected]

Szabó

CONTACT

[email protected]

0614599100 ext. 1155

Sponsors and collaborators

Lead sponsor

Heim Pal Children's Hospital

Other

Registry information

Official study title

INvesTigation the Abnormality of Detrusor ConTractility by Uroflowmetry in Diabetic Children (INTACT Trial) - a Prospective, Cross-sectional, Observational, Controlled Study

Acronym: INTACT

Important dates

Study start
2022
Primary completion
2023
Study completion
2027
First posted
Feb 21, 2022
Registry last updated
Aug 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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