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Sponsored by: |
University of Chicago |
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Information provided by: | University of Chicago |
ClinicalTrials.gov Identifier: | NCT00228345 |
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 |
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Idiopathic Axonal Polyneuropathy Abnormal OGTT |
Procedure: Optical coherence tomography,Fluorescein angiography |
Phase I |
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 |
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) |
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.
Ages Eligible for Study: | 50 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
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.
United States, Illinois | |
University of Chicago | |
Chicago, Illinois, United States, 60637 |
Principal Investigator: | Kourosh Rezania, MD | University of Chicago |
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 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Idiopathic Axonal Polyneuropathy abnormal OGTT |
Metabolic Diseases Hyperglycemia Neuromuscular Diseases Peripheral Nervous System Diseases |
Glucose Intolerance Polyneuropathies Glucose Metabolism Disorders Metabolic Disorder |
Metabolic Diseases Hyperglycemia Neuromuscular Diseases Peripheral Nervous System Diseases |
Nervous System Diseases Glucose Intolerance Polyneuropathies Glucose Metabolism Disorders |