Nerve Conduction Velocity in Diabetic Children

NCT01017718 | Completed DMC

• 1 other identifier: 01
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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)?

Conditions

Type 1 Diabetes Mellitus

Keywords

Diabetes mellitus type I; nerve conduction velocity; Young score; long term vascular complications

Outcome Measures

Primary Outcomes (1)

• 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?

  One electrophysiological investigation (nerve conduction velocity)

Secondary Outcomes (1)

• Is there a correlation between nerve conduction velocity in our study patients and the Young Score?

  One clinical investigation (Young score)

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 with diabetes mellitus type 1 (duration of disease \> 1 year, age 8 to 18a, insulin requirement \> 0.5 IU/kg/d)

You may qualify if:

• Children and adolescents with diabetes mellitus type 1 (duration of disease \> 1 year, age 8 to 18a, insulin requirement \> 0.5 IU/kg/d)

You may not qualify if:

• No consent
• Diabetic children with duration of diabetes \< 1 year, age \<8 or \>18 year or insulin requirement \> 0.5 IU/kg/d
• Blood glucose levels \<50 or \>350 mg/dl
• Children with chronic diseases, handicapped children, children with cancer, chronic renal impairment, or neurological diseases

Sponsors & Collaborators

• Landeskrankenhaus Feldkirch: lead

Study Sites (1)

Department of Pediatrics, University Teaching Hospital, Landeskrankenhaus Feldkirch

Feldkirch, 6800, Austria

Location

Related Publications (6)

• Trotta D, Verrotti A, Salladini C, Chiarelli F. Diabetic neuropathy in children and adolescents. Pediatr Diabetes. 2004 Mar;5(1):44-57. doi: 10.1111/j.1399-543X.2004.00041.x.

  PMID: 15043690 BACKGROUND

• dos Santos LH, Bruck I, Antoniuk SA, Sandrini R. Evaluation of sensorimotor polyneuropathy in children and adolescents with type I diabetes: associations with microalbuminuria and retinopathy. Pediatr Diabetes. 2002 Jun;3(2):101-8. doi: 10.1034/j.1399-5448.2002.30207.x.

  PMID: 15016164 BACKGROUND

• Nelson D, Mah JK, Adams C, Hui S, Crawford S, Darwish H, Stephure D, Pacaud D. Comparison of conventional and non-invasive techniques for the early identification of diabetic neuropathy in children and adolescents with type 1 diabetes. Pediatr Diabetes. 2006 Dec;7(6):305-10. doi: 10.1111/j.1399-5448.2006.00208.x.

  PMID: 17212597 BACKGROUND

• Meh D, Denislic M. Subclinical neuropathy in type I diabetic children. Electroencephalogr Clin Neurophysiol. 1998 Jun;109(3):274-80. doi: 10.1016/s0924-980x(98)00017-4.

  PMID: 9741795 BACKGROUND

• Hyllienmark L, Brismar T, Ludvigsson J. Subclinical nerve dysfunction in children and adolescents with IDDM. Diabetologia. 1995 Jun;38(6):685-92. doi: 10.1007/BF00401840.

  PMID: 7672490 BACKGROUND

• Dorchy H, Noel P, Kruger M, de Maertelaer V, Dupont E, Toussaint D, Pelc S. Peroneal motor nerve conduction velocity in diabetic children and adolescents. Relationships to metabolic control, HLA-DR antigens, retinopathy, and EEG. Eur J Pediatr. 1985 Nov;144(4):310-5. doi: 10.1007/BF00441770.

  PMID: 3865772 BACKGROUND

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, Prof

  Landeskrankenhaus Feldkirch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Simma B, MD

Study Record Dates

• First Submitted: November 20, 2009
• First Posted: November 23, 2009
• Study Start: May 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2011
• Last Updated: September 27, 2011

Record last verified: 2011-09

Locations

AU (1)