diabetes
Conditions
Interventions
Sponsors
Shanghai jiaotong University School of Medicine, Renji Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: Diabetic: 1. age >=18 years. 2. meets the diagnostic criteria of the Chinese Diabetes Society guidelines (2020) , i.e. satisfies any of the following conditions: Typical symptoms of diabetes (polydipsia, polyuria, polyphagia, unexplained weight loss) with fasting blood glucose >=7.0 mmol/L. Random blood glucose >=11.1 mmol/L. OGTT >=11.1 mmol/L at 2 hours. Glycated hemoglobin (HbA1C) >=6.5% . 3. patients with diabetic neuropathic pain must meet: the diagnostic criteria for T2DM according to the Chinese guidelines for the prevention and treatment of T2DM (2020 edition) ; Spontaneous neuralgia and numbness (mainly in the lower extremities, with burning, knife-cutting, and acupuncture-like pain, often accompanied by nocturnal exacerbations and/or sleep disorders) ; Ankle reflex, 10G monofilament pressure sensation, 128Hz tuning fork vibration sensation and acupuncture pain sensation were absent. 4. volunteer to participate in the study and sign an informed consent form. Healthy controls: 1. age, sex, and education were matched to the diabetes group. 2. free of diabetes and other metabolic diseases. 3. volunteer to participate in the study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Combined with other diseases that may cause peripheral neuropathy, such as: hyperthyroidism or hypothyroidism. uremia. chronic liver disease. autoimmune diseases (e.g. systemic lupus erythematosus, rheumatoid arthritis) . severe alcoholism. tumor. Heavy Metal Poisoning. drug-induced neuropathy (E. G. Chemotherapy drugs) . hereditary neuropathy. 2. Previous neurological disorder history, such as stroke, brain trauma, Parkinson's disease, multiple sclerosis, etc. . 3. Acute infection period or nearly 1 month have a history of acute infection. 4. With severe heart, liver and kidney dysfunction. 5. Mental illness or cognitive impairment, inability to understand and cooperate with research. 6. Women during pregnancy or lactation. 7. Participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraepidermal nerve fiber density;Corneal nerve fiber density; | — |
Secondary
| Measure | Time frame |
|---|---|
| Neutrophil lymphocyte ratio;Nerve conduction velocity;Quantitative sensory testing;Pain VAS ;Sympathetic nervous system skin reaction (SSR); | — |
Countries
China
Contacts
Public ContactYinhui Fan
Renji Hospital, No. 160 Pujian Road, Pudong New Area, Shanghai
Outcome results
None listed