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

NCT01512030 | Completed

• 1 other identifier: 02
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• What is the long term development of diabetic neuropathy? Is there a significant deterioration or improvement in nerve conduction during the follow up period?

  5-years

Secondary Outcomes (5)

• Correlation to mean HbA1c

  5 years

• mean BMI

  5 years

• Blood pressure

  5 years

• Retinopathy

  5 years

• Nephropathy

  5 years

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Landeskrankenhaus Feldkirch: lead

Study Sites (1)

Dep. of Pediatrics, Academic Teaching Hospital, Landeskrankenhaus Feldkirch

Feldkirch, 6900, Austria

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Burkhard Simma, MD

  Dep. of Pedaitrics Academic Teaching Hospital, Landeskrankenhaus Feldkirch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Professor

Study Record Dates

• First Submitted: January 10, 2012
• First Posted: January 19, 2012
• Study Start: December 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 7, 2016

Record last verified: 2016-09

Locations

AU (1)