The Significance of Glucose Intolerance in the Pathogenesis of Idiopathic Axonal Polyneuropathy

This study has been terminated.
(Study Completed)
Sponsor:
Information provided by:
University of Chicago
ClinicalTrials.gov Identifier:
NCT00228345
First received: September 26, 2005
Last updated: April 24, 2008
Last verified: April 2008

September 26, 2005
April 24, 2008
January 2004
January 2005   (final data collection date for primary outcome measure)
we will determine the incidence of subtle damage to kidneys, eyes and also look for other factors associated with abnormal glucose handling in patients with neuropathy and abnormal OGTT and compare it to age matched controls with normal OGTT. [ Time Frame: 48 hrs ] [ Designated as safety issue: No ]
Finding a higher incidence of retinopathy or nephropathy in patients with idiopathic neuropathy and IGT will support the hypothesis of a causal relation between IGT and idiopathic neuropathy.
Complete list of historical versions of study NCT00228345 on ClinicalTrials.gov Archive Site
we will determine the incidence of subtle damage to kidneys, eyes and also look for other factors associated with abnormal glucose handling in patients with neuropathy and abnormal OGTT and compare it to age matched controls with normal OGTT [ Time Frame: 48 hrs ] [ Designated as safety issue: No ]
Not Provided
Not Provided
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The Significance of Glucose Intolerance in the Pathogenesis of Idiopathic Axonal Polyneuropathy
The Significance of Glucose Intolerance in the Pathogenesis of Idiopathic Axonal Polyneuropathy

The purpose of this study is to determine whether impaired glucose handling (abnormality in the way the body processes blood sugar) can cause a neuropathy (damage to the nerves).

Neuropathy of undetermined etiology is a common disease that usually starts at the sixth to seventh decades. It can cause significant pain and disability. Previous studies have demonstrated increased prevalence of abnormal glucose handling, when these patients were tested with oral glucose tolerance test (OGTT). On the other hand, many of the neuropathy patients suffer from pain and depression and obesity; and abnormal OGTT in these patients may be the result of these factors. We assume that if abnormal handling of blood sugar is the cause of neuropathy, these patients may have evidence of damage to other organs (like eyes and kidneys) as a result of abnormal blood sugar. In a pilot study, we will determine the incidence of subtle damage to kidneys, eyes and also look for other factors associated with abnormal glucose handling in patients with neuropathy and abnormal OGTT and compare it to age matched controls with normal OGTT.

Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Idiopathic Axonal Polyneuropathy
  • Abnormal OGTT
Procedure: Optical coherence tomography,Fluorescein angiography
Not Provided
  • Dive D, Lievens I, Moonen G, Wang FC. [Diabetic peripheral neuropathy] Rev Med Liege. 2005 May-Jun;60(5-6):490-7. Review. French.
  • 1. McLeod, J.G., et al., Chronic polyneuropathy of undetermined cause. J Neurol Neurosurg Psychiatry, 1984. 47(5): p. 530-5. 2. Dyck, P.J., K.F. Oviatt, and E.H. Lambert, Intensive evaluation of referred unclassified neuropathies yields improved diagnosis. Ann Neurol, 1981. 10(3): p. 222-6. 3. Wolfe, G.I., et al., Chronic cryptogenic sensory polyneuropathy: clinical and laboratory characteristics. Arch Neurol, 1999. 56(5): p. 540-7. 4. Notermans, N.C., et al., Chronic idiopathic polyneuropathy presenting in middle or old age: a clinical and electrophysiological study of 75 patients. J Neurol Neurosurg Psychiatry, 1993. 56(10): p. 1066-71. 5. Beghi, E. and M.L. Monticelli, Chronic symmetric symptomatic polyneuropathy in the elderly: a field screening investigation of risk factors for polyneuropathy in two Italian communities. Italian General Practitioner Study Group (IGPST). J Clin Epidemiol, 1998. 51(8): p. 697-702. 6. Notermans, N.C. and J.H. Wokke, Chronic idiopathic axonal polyneuropathy. Muscle Nerve, 1996. 19(12): p. 1637-8. 7. Dyck, P.J., Cryptogenic sensory polyneuropathy. Arch Neurol, 1999. 56(5): p. 519-20. 8. Wolfe, G.I. and R.J. Barohn, Cryptogenic sensory and sensorimotor polyneuropathies. Semin Neurol, 1998. 18(1): p. 105-11. 9. Monticelli, M.L. and E. Beghi, Chronic symmetric polyneuropathy in the elderly. A field screening investigation in two regions of Italy: background and methods of assessment. The Italian General Practitioner Study Group (IGPSG). Neuroepidemiology, 1993. 12(2): p. 96-105. 10. Beghi, E. and M.L. Monticelli, Diabetic polyneuropathy in the elderly. Prevalence and risk factors in two geographic areas of Italy. Italian General Practitioner Study Group (IGPSG). Acta Neurol Scand, 1997. 96(4): p. 223-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
January 2005
January 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

Inclusion criteria (for the subjects) will include peripheral neuropathy, age more than 50 years, and a negative workup for neuropathy (aside from an abnormal OGTT). Age matched controls will have no history of diabetes or baseline retinal disease . A workup to rule out other causes of peripheral neuropathy, and an OGTT, will be performed prior to participation in the study.

Exclusion Criteria:

Patients with abnormal OGTT in the diabetic range will not be included.

Both
50 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00228345
12896A
Not Provided
Kourosh Rezania, M.D., University of Chicago
University of Chicago
Not Provided
Principal Investigator: Kourosh Rezania, MD University of Chicago
University of Chicago
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP