Clinical Trials Logo

Clinical Trial Summary

Diabetes mellitus type I is an increasing burden for more and younger children. Therapy should avoid long-term complications as macrovascular diseases and diabetic nephropathy, retinopathy and diabetic neuropathy (DN). There is considerable uncertainty about the prevalence of DN due to a lack of large epidemiological studies and consensus on diagnostic criteria. Nerve conduction velocity studies are regarded as the "gold standard" for investigating neuropathies.

We plan a prospective study by investigating the peripheral nerve conduction velocity in a population of diabetic children. At the same time-points, we will do a neurological examination using the Young Score, a clinical score of peripheral neuropathy [10]. The results obtained will be related to other long-term vascular complications (nephropathy, retinopathy), glycaemic control, duration of diabetes, insulin dose regime, hours of sports/week, and BMI


Clinical Trial Description

The number of newly diagnosed patients with diabetes mellitus type I increases every year, with the patients becoming younger. The Austrian Diabetes Incidence Study Group demonstrated a significant and constant increase in the incidence rate from 12.0 to 18.4/100,000 in children and adolescents ≤15 years of age from 1999 to 2007 [7]. So, we are confronted with more and more children and adolescents suffering from complications which determine long-term outcome. Chronic disease and complications have an important impact on quality and expectation of life and on health resources.

Among the long-term complications of diabetes, vascular complications including retinopathy, nephropathy, neuropathy, and macrovascular disease are the most prevalent [2]. The main therapeutic goal is to avoid these 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 [2]. With regard to diabetic neuropathy (DN) there is still uncertainty about the time frame, intensity and diagnostic method of choice, despite it is a significant source of morbidity and mortality [3]. Additionally, there is considerable uncertainty about the prevalence of DN due to a lack of large epidemiological studies and consensus on diagnostic criteria [4].

The American Academy of Neurology suggests a combination of objective and symptoms, signs and electrophysiology provides the most accurate diagnosis of distal symmetric polyneuropathy [5]. Nerve conduction studies are considered by many as the "gold standard" for nerve damage and the most consistent indicator of (sub-)clinical neuropathy [6].

So far, several cross-sectional studies have been conducted on nerve conduction velocity in diabetic children. The results in regard of prevalence are largely divergent. We found that 15 out of 39 patients (38.5%) had a pathological nerve conduction velocity. This result neither correlated to a clinical symptom score (Young Score which consist of a Neurological Deficiency Score, NDS and a Neuropathy Symptom Score, NSS) [10], nor to mean HbA1c, patients age, duration of diabetes, body mass index, insulin regime, hours of sports or metabolic testing results.

Only one long-term prospective study addressing the issue of the development of diabetic neuropathy in a juvenile population was done so far [8]. To better understand the long term development of diabetic neuropathy we plan to study the peripheral nerve conduction velocity in a population of diabetic children from our outpatient clinic. At the same time, we will do a neurological examination using the Young Score, a clinical score of peripheral neuropathy [10].

The results obtained will be related to other long-term vascular complications (nephropathy, retinopathy), glycaemic control, duration of diabetes, insulin dose regime, hours of sports/week, and BMI ;


Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT01512030
Study type Observational
Source Landeskrankenhaus Feldkirch
Contact
Status Completed
Phase N/A
Start date December 2011
Completion date December 2015

See also
  Status Clinical Trial Phase
Recruiting NCT04638556 - Effect of Circulating lncRNAs on Type 2 Diabetic Peripheral Neuropathy
Completed NCT05580705 - Effects of Vibration Therapy in Addition to Routine Physical Therapy in Patients With Diabetic Neuropathy N/A
Terminated NCT01620775 - MR(Magnetic Resonance) Imaging of Neurotransmitters in Chronic Pain N/A
Completed NCT02127762 - The Effect of Mindfulness Based Stress Reduction in Patients With Painful Diabetic Peripheral Neuropathy N/A
Completed NCT00835757 - Diffusion Tensor Imaging of Sural Nerves in Diabetic Peripheral Neuropathy N/A
Recruiting NCT00553592 - Double Blind RCT of Bicifadine SR in Outpatients With Chronic Neuropathic Pain Associated With Diabetes Phase 2
Recruiting NCT05863793 - Clinical Study of Acupuncture in the Treatment of Diabetic Peripheral Neuropathy N/A
Withdrawn NCT05041816 - Peripheral Nerve Responses to Focal Vibration and Implications in Pain and Mobility for Patients With Diabetic Peripheral Neuropathy N/A
Recruiting NCT06074562 - A Study of LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain Phase 2
Recruiting NCT04457531 - LiuWeiLuoBi Granule for the Treatment of Diabetic Peripheral Neuropathy Early Phase 1
Completed NCT02947828 - Polyneuropathy in Diabetes Mellitus Type 2
Completed NCT02056431 - Balancing Treatment Outcomes and Medication Burden Among Patients With Symptomatic Diabetic Peripheral Neuropathy N/A
Completed NCT01681290 - Safety and Efficacy of CBX129801 in Patients With Type 1 Diabetes Phase 2
Completed NCT01474772 - Efficacy and Safety Study of Pregabalin in the Treatment of Pain on Walking in Patients With Diabetic Peripheral Neuropathy (DPN) Phase 3
Completed NCT01086150 - Use of Topical Lidocaine to Reduce Pain in Patients With Diabetic Neuropathy Phase 2/Phase 3
Completed NCT03447756 - Titration Study of ABX-1431 Phase 1
Completed NCT04688671 - Efficacy and Safety of ETX-018810 for the Treatment of Diabetic Peripheral Neuropathic Pain Phase 2
Completed NCT04984044 - Effect of Vitamin D in Patients With Diabetic Peripheral Neuropathy to Alleviate Pain and Improvement of Symptoms N/A
Completed NCT06130917 - Effects of Multisystem Exercise on Balance, Postural Stability, Mobility and Pain in Patients With DPN. N/A
Completed NCT01496365 - Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy Phase 2