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To detect small fiber neuropathy in patients with possible or established diabetic peripheral neuropathy (DPN) by skin biopsy and explore clinical characteristics and pathological features in Chinese patients with diabetes.
Small fiber neuropathy (SFN) is a subtype of diabetic neuropathy, patients with SFN often manifest as paresthesia of warmth, cold, pinprick and so on, especially affect ed length-dependent area. Skin biopsy is an effective method to diagnose SFN with high diagnostic accuracy. The procedure is simple and minimally, and the wound usually heals within a few days. However, skin biopsy is not widely used in diagnose of SFN in Chinese patients with diabetes. This study is aimed to establish a normal reference range of intraepidermal nerve fiber density (IENFD) in the Chinese population, and to detect SFN in Chinese patients with diabetes by skin biopsy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sudoscan、nerve conduction tests | Device | To evaluate sudomotor nerve and macrofibropathy. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of small fiber neuropathy in Chinese patients with diabetes by calculating intraepidermal nerve fiber density (IENFD) via skin biopsy | Calculating intraepidermal nerve fiber density (IENFD) is considered as as gold criteria of diagnosis of small fiber neuropathy. | December, 2019 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of diagnostic sensitivity and specificity of sudoscan in Chinese diabetic patients with small fiber neuropathy compared with intraepidermal nerve fiber density (IENFD) | Sudoscan is used to as an autonomic nerve assessment tool with objective and stable operations, which measures the function of sweat glands by stimulating a low voltage current ( < 4 volts) and detects the electrochemical reaction between the electrodes and chloride ions in both hands and feet. Results are presented as electrochemical skin conductance in hands (HESC) and feet (FESC), asymmetry ratio value in hands (HASYM) and feet (FASYM). We use intraepidermal nerve fiber density (IENFD) measured by skin biopsy as the gold standard, sudoscan is used to evaluate its diagnostic efficiency including sensitivity and specificity of small fiber neuropathy. |
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Inclusion Criteria:
Exclusion Criteria:
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Chinese patients complaining symptoms of neuropathies after diagnosed diabetes.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dalong Zhu, MD, PhD | Contact | 13805150781 | zhudldr@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University | Recruiting | Nanjing | Jiangsu | 210008 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16190912 | Result | Lauria G, Cornblath DR, Johansson O, McArthur JC, Mellgren SI, Nolano M, Rosenberg N, Sommer C; European Federation of Neurological Societies. EFNS guidelines on the use of skin biopsy in the diagnosis of peripheral neuropathy. Eur J Neurol. 2005 Oct;12(10):747-58. doi: 10.1111/j.1468-1331.2005.01260.x. | |
| 27215701 | Result |
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The demographic and biochemical indicators of this study.
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| ID | Term |
|---|---|
| D000071075 | Small Fiber Neuropathy |
| D003929 | Diabetic Neuropathies |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
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Skin sample, blood serum (approximately 3ml), and whole blood (approximately 6ml).
| December, 2019 |
| Van Acker N, Rage M, Sluydts E, Knaapen MW, De Bie M, Timmers M, Fransen E, Duymelinck C, De Schepper S, Anand P, Meert T, Plaghki L, Cras P. Automated PGP9.5 immunofluorescence staining: a valuable tool in the assessment of small fiber neuropathy? BMC Res Notes. 2016 May 23;9:280. doi: 10.1186/s13104-016-2085-4. |
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |