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

Abnormal OGTT Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00228345
• Other study ID #: 12896A
• Status: Terminated
• Phase: Phase 1
• First received: September 26, 2005
• Last updated: September 4, 2013
• Start date: January 2004
• Est. completion date: January 2005

Study information

• Verified date: September 2013
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: January 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Abnormal OGTT
• Glucose Intolerance
• Idiopathic Axonal Polyneuropathy
• Polyneuropathies

Intervention

Procedure:
• Optical coherence tomography,Fluorescein angiography

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

References & Publications (2)

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.

Dive D, Lievens I, Moonen G, Wang FC. [Diabetic peripheral neuropathy]. Rev Med Liege. 2005 May-Jun;60(5-6):490-7. Review. French. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		48 hrs	No
Secondary	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		48 hrs	No