Prevalence of Peripheral Neuropathy in Children and Adolescents With Type I Diabetes Mellitus: a Prospective Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2012 by Landeskrankenhaus Feldkirch
Sponsor:
Information provided by (Responsible Party):
Burkhard Simma, Landeskrankenhaus Feldkirch
ClinicalTrials.gov Identifier:
NCT01512030
First received: January 10, 2012
Last updated: January 18, 2012
Last verified: January 2012
  Purpose

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


Condition
Diabetes Mellitus Type I
Diabetic Peripheral Neuropathy
Nerve Conduction Study Not Performed

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study of Peripherla Neuropathy in Diabetic Type I

Resource links provided by NLM:


Further study details as provided by Landeskrankenhaus Feldkirch:

Primary Outcome Measures:
  • What is the long term development of diabetic neuropathy? Is there a significant deterioration or improvement in nerve conduction during the follow up period? [ Time Frame: 5-years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation to mean HbA1c [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • mean BMI [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Retinopathy [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Nephropathy [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: December 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Detailed 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

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children and adolescents 8 to 18 years suffering from diabetes mellitus type I for more than one year.

Criteria

Inclusion Criteria:

  • 8 to 18 years suffering from diabetes mellitus type I for more than one year.

Exclusion Criteria:

  • Children who are unable to understand informed consent
  • Diabetic children with duration of diabetes < 1 year, age <8 or >18
  • Insulin < 0.5IE/kg/d
  • Blood glucose before examination below 50 or above 350mg/dL
  • Children with chronic diseases, handicapped children, children with cancer, chronic renal impairment, or neurological diseases
  • Children who are on medications that can produce peripheral neuropathy, i.e antineoplastic drugs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01512030

Contacts
Contact: Burkhard Simma, MD 004355223032900 burkhard.simma@lkhf.at

Locations
Austria
Dep. of Pediatrics, Academic Teaching Hospital, Landeskrankenhaus Feldkirch Recruiting
Feldkirch, Austria, 6900
Contact: burkhard Simma, MD    0043552230 ext 2900    burkhard.simma@lkhf.at   
Contact: burkhard simma       burkhard.simma@lkhf.at   
Sub-Investigator: Isabella Höliner, MD         
Sponsors and Collaborators
Landeskrankenhaus Feldkirch
Investigators
Principal Investigator: Burkhard Simma, MD Dep. of Pedaitrics Academic Teaching Hospital, Landeskrankenhaus Feldkirch
  More Information

No publications provided

Responsible Party: Burkhard Simma, Medical Doctor, Professor, Landeskrankenhaus Feldkirch
ClinicalTrials.gov Identifier: NCT01512030     History of Changes
Other Study ID Numbers: 02
Study First Received: January 10, 2012
Last Updated: January 18, 2012
Health Authority: Austria: Ethikkommission

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Diabetes Mellitus
Diabetic Neuropathies
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 22, 2014