INvesTigation the Abnormality of Detrusor ConTractility by Uroflowmetry in Diabetic Children (INTACT Trial) - a Prospective, Cross-sectional, Observational, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- diagnostic accuracy of uroflowmetry test 1.4
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •5-18 years (boys, girls) with type 1, type 2 and monogenic DM
排除标准
- •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
结局指标
主要结局
diagnostic accuracy of uroflowmetry test 1.4
时间窗: change from baseline at 36 months
sensitivity, specificity, positive predictive value, negative predictive value
diagnostic accuracy of uroflowmetry test 1.1
时间窗: baseline
sensitivity, specificity, positive predictive value, negative predictive value
diagnostic accuracy of uroflowmetry test 1.2
时间窗: change from baseline at 12 months
sensitivity, specificity, positive predictive value, negative predictive value
diagnostic accuracy of uroflowmetry test 1.3
时间窗: change from baseline at 24 months
sensitivity, specificity, positive predictive value, negative predictive value
diagnostic accuracy of uroflowmetry test 1.5
时间窗: change from baseline at 48 months
sensitivity, specificity, positive predictive value, negative predictive value
diagnostic accuracy of uroflowmetry test 1.6
时间窗: change from baseline at 60 months
sensitivity, specificity, positive predictive value, negative predictive value
diagnostic accuracy of cardiovascular autonomic dysfunction test 2.1
时间窗: baseline
sensitivity, specificity, positive predictive value, negative predictive value
diagnostic accuracy of cardiovascular autonomic dysfunction test 2.2
时间窗: change from baseline at 12 months
sensitivity, specificity, positive predictive value, negative predictive value
diagnostic accuracy of cardiovascular autonomic dysfunction test 2.6
时间窗: change from baseline at 60 months
sensitivity, specificity, positive predictive value, negative predictive value
diagnostic accuracy of peripheral nerve conduction test 3.4
时间窗: change from baseline at 36 months
sensitivity, specificity, positive predictive value, negative predictive value
diagnostic accuracy of peripheral nerve conduction test 3.6
时间窗: change from baseline at 60 months
sensitivity, specificity, positive predictive value, negative predictive value
diagnostic accuracy of cardiovascular autonomic dysfunction test 2.3
时间窗: change from baseline at 24 months
sensitivity, specificity, positive predictive value, negative predictive value
diagnostic accuracy of cardiovascular autonomic dysfunction test 2.5
时间窗: change from baseline at 48 months
sensitivity, specificity, positive predictive value, negative predictive value
diagnostic accuracy of peripheral nerve conduction test 3.1
时间窗: baseline
sensitivity, specificity, positive predictive value, negative predictive value
diagnostic accuracy of cardiovascular autonomic dysfunction test 2.4
时间窗: change from baseline at 36 months
sensitivity, specificity, positive predictive value, negative predictive value
diagnostic accuracy of peripheral nerve conduction test 3.2
时间窗: change from baseline at 12 months
sensitivity, specificity, positive predictive value, negative predictive value
diagnostic accuracy of peripheral nerve conduction test 3.3
时间窗: change from baseline at 24 months
sensitivity, specificity, positive predictive value, negative predictive value
diagnostic accuracy of peripheral nerve conduction test 3.5
时间窗: change from baseline at 48 months
sensitivity, specificity, positive predictive value, negative predictive value
次要结局
- metabolic status 1.2(change from baseline at 12 months)
- metabolic status 1.1(baseline)
- metabolic status 1.4(change from baseline at 36 months)
- metabolic status 2.4(change from baseline at 36 months)
- metabolic status 2.6(change from baseline at 60 months)
- metabolic status 3.6(change from baseline at 60 months)
- metabolic status 4.6(change from baseline at 60 months)
- metabolic status 1.3(change from baseline at 24 months)
- metabolic status 1.5(change from baseline at 48 months)
- metabolic status 1.6(change from baseline at 60 months)
- metabolic status 2.1(baseline)
- metabolic status 2.2(change from baseline at 12 months)
- metabolic status 2.3(change from baseline at 24 months)
- metabolic status 2.5(change from baseline at 48 months)
- metabolic status 3.1(baseline)
- metabolic status 3.2(change from baseline at 12 months)
- metabolic status 3.3(change from baseline at 24 months)
- metabolic status 3.4(change from baseline at 36 months)
- metabolic status 4.1(baseline)
- metabolic status 3.5(change from baseline at 48 months)
- metabolic status 5.2(change from baseline at 12 months)
- metabolic status 5.4(change from baseline at 36 months)
- metabolic status 5.5(change from baseline at 48 months)
- metabolic status 5.6(change from baseline at 60 months)
- metabolic status 6.4(change from baseline at 36 months)
- metabolic status 6.5(change from baseline at 48 months)
- metabolic status 6.6(change from baseline at 60 months)
- clinical symptoms of diabetic patients will be measured and compared to healthy children. 8.1(baseline)
- clinical symptoms of diabetic patients will be measured and compared to healthy children. 8.5(change from baseline at 48 months)
- clinical symptoms of diabetic patients will be measured and compared to healthy children. 8.6(change from baseline at 60 months)
- metabolic status 4.2(change from baseline at 12 months)
- metabolic status 4.3(change from baseline at 24 months)
- metabolic status 6.2(change from baseline at 12 months)
- metabolic status 6.3(change from baseline at 24 months)
- metabolic status 7.1(baseline)
- metabolic status 7.2(change from baseline at 12 months)
- metabolic status 7.6(change from baseline at 60 months)
- metabolic status 7.5(change from baseline at 48 months)
- metabolic status 4.4(change from baseline at 36 months)
- metabolic status 4.5(change from baseline at 48 months)
- metabolic status 6.1(baseline)
- metabolic status 7.4(change from baseline at 36 months)
- clinical symptoms of diabetic patients will be measured and compared to healthy children. 8.2(change from baseline at 12 months)
- metabolic status 5.1(baseline)
- metabolic status 5.3(change from baseline at 24 months)
- metabolic status 7.3(change from baseline at 24 months)
- clinical symptoms of diabetic patients will be measured and compared to healthy children. 8.3(change from baseline at 24 months)
- clinical symptoms of diabetic patients will be measured and compared to healthy children. 8.4(change from baseline at 36 months)
研究者
László Szabó MD, PhD, med habil.
Prof. Dr. László Szabó M.D., PhD., DSc., Dr., Habil. pediatric nephrologist, urodynamic specialist
Heim Pal Children's Hospital