The Significance of Glucose Intolerance in the Pathogenesis of Idiopathic Axonal Polyneuropathy - Full Text View

Sponsored by:	University of Chicago
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00228345

Purpose

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).

Condition	Intervention	Phase
Idiopathic Axonal Polyneuropathy Abnormal OGTT	Procedure: Optical coherence tomography,Fluorescein angiography	Phase I

Drug Information available for: D&C Yellow no. 8 Fluorescein

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Active Control, Single Group Assignment
Official Title:	The Significance of Glucose Intolerance in the Pathogenesis of Idiopathic Axonal Polyneuropathy

Further study details as provided by University of Chicago:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	40
Study Start Date:	January 2004
Study Completion Date:	January 2005
Estimated Primary Completion Date:	January 2005 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	50 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00228345

Locations

United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637

Sponsors and Collaborators

University of Chicago

Investigators

Principal Investigator:

Kourosh Rezania, MD

University of Chicago

More Information

Publications:

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.

Responsible Party:	University of Chicago ( Kourosh Rezania, M.D. )
Study ID Numbers:	12896A
Study First Received:	September 26, 2005
Last Updated:	April 24, 2008
ClinicalTrials.gov Identifier:	NCT00228345
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Chicago:

Idiopathic Axonal Polyneuropathy
abnormal OGTT

Study placed in the following topic categories:

Metabolic Diseases
Hyperglycemia
Neuromuscular Diseases
Peripheral Nervous System Diseases

Glucose Intolerance
Polyneuropathies
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on February 12, 2009