Nerve Conduction Velocity in Diabetic Children
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      The investigators intend to study children and adolescents from 8 to 18 years suffering from
      diabetes mellitus type 1 for more than one year. The patients will undergo a detailed
      clinical examination for anthropometric data, blood pressure, blood and urine. Motor and
      sensory nerve conduction velocity will be examined by electrical stimulation using surface
      patch electrodes. The nerves to be examined are the nervus tibialis anterior, nervus medianus
      and nervus peroneus.

      Primary outcome:

      How many children and adolescents suffering from diabetes mellitus type 1 (duration of
      disease > 1 year, age 8 to 18a, insulin requirement > 0.5 IU/kg/d) show pathological nerve
      conduction velocity?

      Secondary outcome:

      Is there a significant difference in nerve conduction velocity between the group of diabetic
      patients and the control group of healthy young people? Does the quality of disease control
      have an influence on nerve conduction velocity? Is there a correlation between nerve
      conduction velocity in our study patients and the Young Score? Is there a correlation between
      pathological nerve conduction velocity and other long-term vascular complications
      (nephropathy, retinopathy)?
    

Detailed description: 
      Diabetes mellitus type 1 is a chronic disease in which the pancreas no longer produces enough
      insulin and the glucose in the blood cannot be absorbed into the cells of the body. The main
      symptom is hyperglycemia. After 10 to 15 years of disease long-term vascular complications
      including retinopathy, nephropathy, neuropathy, and macrovascular disease are seen. Among the
      most common long-term complications of diabetes, diabetic neuropathy (DN) is a significant
      source of morbidity and mortality. There is considerable uncertainty about the prevalence of
      DN due to a lack of large epidemiological studies and consensus on diagnostic criteria with
      data variation ranging from 5% to 100%. DN is thought to result from diabetic microvascular
      injury involving small blood vessels that supply nerves (vasa nervorum). It is a set of
      heterogeneous clinical syndromes that affect distinct regions of the nervous system,
      individually or combined. The investigators differentiate autonomic and peripheral
      neuropathy: Clinical presentation of autonomic neuropathy includes postural hypotension,
      vomiting, diarrhea, bladder paresis, impotence, sweating abnormalities, and gastric fullness.
      Peripheral neuropathy presents as altered pain sensations (dys-, para-, hypo- or
      hyperesthesia), burning, and either superficial or deep pain. The examination of choice for
      the diagnosis of peripheral neuropathy is to determine nerve conduction velocity.

      One of the main goals in treating children and adolescents suffering from diabetes mellitus
      type I is to avoid long-term complications by early detection of clinical or, even better,
      subclinical signs. For this reason, the International Society for Pediatric and Adolescent
      Diabetes (ISPAD) periodically issues Clinical Practice Consensus Guidelines, particularly for
      screening for vascular complications. With regard to DN there is still uncertainty about the
      time frame, intensity and diagnostic method of choice.

      The investigators aim to examine children and adolescents from 8 to 18 years suffering from
      diabetes mellitus type I for more than one year with an insulin requirement of more than 0.5
      IU/kg/d. The investigators will exclude children with other chronic diseases, handicapped
      children or children suffering from cancer or chronic renal impairment, as well as children
      with other neurological diseases which can also cause a change in nerve conduction velocity,
      and children with blood glucose levels below 50 or above 350 mg/dl. At the time of the annual
      check-up the patients will undergo a detailed examination for anthropometric data, blood
      pressure, blood and urine. Thereafter, motor and sensory nerve conduction velocity will be
      determined by electrical stimulation using surface patch electrodes. The nerves to be
      investigated are the nervus tibialis anterior, nervus medianus and nervus peroneus. Finally,
      the patient will undergo a neurological investigation to calculate his Young Score
      (Neuropathy Symptom Score).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        children and adolescents with diabetes mellitus type 1 (duration of disease > 1 year, age 8
        to 18a, insulin requirement > 0.5 IU/kg/d)
      
Keywords: Diabetes mellitus type I; nerve conduction velocity; Young score; long term vascular complications