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The purpose of this study is to evaluate the distal sensory nerves of the feet, namely, the dorsal sural, medial dorsal cutaneous and medial plantar nerves, in patients with impaired glucose tolerance and diabetes mellitus type 2 and compare these parameters to those from healthy participants.
Diabetic Peripheral polyneuropathy (DPP) presents as a slowly progressive primary sensory deficit in length dependent fashion, to result in the classic stocking glove distribution. There is recent evidence to indicate that patients with impaired glucose tolerance ( IGT) on OGTT, the prediabetic stage, have three times the prevalence of distal peripheral polyneuropathy than age matched controls. Patients with IGT, even in their preclinical stages, though they have less severe neuropathy than those with diabetes mellitus, have predominant sensory fiber involvement. To support this, other studies of skin biopsies of IGT patients have shown that microvascular abnormalities and neuropathic changes can occur in the prediabetic stage.
Because DPP is length dependent, it is necessary to evaluate the distal sensory nerves, other than the standard sural and superficial peroneal nerves. To support this theory, recent electrodiagnostic studies in DM patients have shown that albeit normal conduction parameters in the above mentioned two nerves, abnormal parameters can be detected in the more distal sensory nerves, such as the dorsal sural nerve, medial plantar nerves and medial dorsal cutaneous nerve.
Although the importance of evaluating the distal sensory nerves has gained much attention, no study has addressed the issue whether NCS parameters of these distal sensory nerves in IGT patients are significantly different from those of healthy controls with no medical condition, and whether these parameters are different to those with patients with diabetes mellitus, who have no previous history of peripheral polyneuropathy.
With this objective in mind, NCS of the distal sensory nerves of the feet were performed to three groups; normal healthy control group, IGT group and diabetes mellitus group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IGT group | IGT diagnosed by endocrinologist |
| |
| DM group | DM diagnosed by endocrinologist and whose primary NCS screening shows SNAP amplitudes of sural and superficial peroneal nerves greater than 10mA DM patients with no previous diagnosis of peripheral polyneuropathy |
| |
| Normal healthy participants | Normal health participants with no previous history of DM, IGT, thyroid disorder, hypercholesterolemia, or other condition associated with peripheral polyneuropathy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nerve conduction studies ( NCS) of the peripheral nerves | Other | Standard NCS of the sural, superficial peroneal sensory nerves, peroneal, tibial motor nerves, radial and median sensory nerves, median motor nerves, F-wave studies of the Tibial and median nerves. NCS of the distal sensory nerves; dorsal sural Medial dorsal cutaneous and medial plantar nerves. |
| Measure | Description | Time Frame |
|---|---|---|
| Nerve conduction parameters | Nerve conduction study (NCS) parameters of the dorsal sural, medial dorsal cutaneous and medial plantar nerves, along with standard NCS of the tibial and peroenal motor, sural, superficial peronea, median and radial sensory nerves. | NCS performed once, within one day after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical neuropathic scoring system | The Toronoto clinical neuropathic score | once, at a single point of time, within one day after enrollment, |
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Inclusion Criteria:
Exclusion Criteria:
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University affiliated medical center
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| Name | Affiliation | Role |
|---|---|---|
| Geun Young Park, MD, PhD | College of Medicine, Catholic University of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catholic University of Medicine, College of Medicine, Bucheon St. Mary's Hospital, Department of Rehabilitation Medicine | Bucheon-si | Kyoungido | 420-717 | South Korea |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| D011115 | Polyneuropathies |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D009353 | Zinostatin |
| ID | Term |
|---|---|
| D053281 | Enediynes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
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|
|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D009930 |
| Organic Chemicals |
| D053280 | Diynes |
| D053279 | Polyynes |
| D000480 | Alkynes |