The Significance of Glucose Intolerance in the Pathogenesis of Idiopathic Axonal Polyneuropathy
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 26, 2005 | ||||
| Last Updated Date | April 24, 2008 | ||||
| Start Date ICMJE | January 2004 | ||||
| Estimated Primary Completion Date | January 2005 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE |
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. | ||||
| Change History | Complete list of historical versions of study NCT00228345 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Significance of Glucose Intolerance in the Pathogenesis of Idiopathic Axonal Polyneuropathy | ||||
| Official Title ICMJE | The Significance of Glucose Intolerance in the Pathogenesis of Idiopathic Axonal Polyneuropathy | ||||
| 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. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Procedure: Optical coherence tomography,Fluorescein angiography | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * |
|
||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | 40 | ||||
| Completion Date | January 2005 | ||||
| Estimated Primary Completion Date | January 2005 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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. |
||||
| Gender | Both | ||||
| Ages | 50 Years to 75 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00228345 | ||||
| Other Study ID Numbers ICMJE | 12896A | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Kourosh Rezania, M.D., University of Chicago | ||||
| Study Sponsor ICMJE | University of Chicago | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | University of Chicago | ||||
| Verification Date | April 2008 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||