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

Primary Purpose

Idiopathic Axonal Polyneuropathy, Abnormal OGTT

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Optical coherence tomography,Fluorescein angiography
Sponsored by
University of Chicago
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Idiopathic Axonal Polyneuropathy focused on measuring Idiopathic Axonal Polyneuropathy, abnormal OGTT

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Chicago

Outcomes

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.

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

Full Information

First Posted
September 26, 2005
Last Updated
September 4, 2013
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT00228345
Brief Title
The Significance of Glucose Intolerance in the Pathogenesis of Idiopathic Axonal Polyneuropathy
Official Title
The Significance of Glucose Intolerance in the Pathogenesis of Idiopathic Axonal Polyneuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Terminated
Why Stopped
Study Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
January 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Axonal Polyneuropathy, Abnormal OGTT
Keywords
Idiopathic Axonal Polyneuropathy, abnormal OGTT

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Optical coherence tomography,Fluorescein angiography
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kourosh Rezania, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16035316
Citation
Dive D, Lievens I, Moonen G, Wang FC. [Diabetic peripheral neuropathy]. Rev Med Liege. 2005 May-Jun;60(5-6):490-7. French.
Results Reference
background
Citation
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.
Results Reference
background

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

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