Diabetic Peripheral Neuropathy
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Age between 40 and 70 years inclusive; (2) Complete clinical medical records; (3) Capable of providing informed consent. 1) Individuals with normal blood sugar: Fasting blood glucose (FBG) = 5.6mmol/L; b. Oral glucose tolerance test (OGTT) = 7.8mmol/L; c. Glycated hemoglobin (HbA1c)5; c. Exclude peripheral neuropathy caused by other diseases; Glycated hemoglobin (HbA1c)<11%; Poor response to routine treatment for at least 3 months, i.e. TCSS score decreased by<3 points or VAS score decreased by<25% compared to before treatment. Conventional treatment includes lifestyle adjustments, blood glucose control, and medication intervention.
Exclusion criteria
Exclusion criteria: (1) A history of continuous use of antibiotics for more than 3 days within 3 months prior to enrollment; (2) Having undergone gastrectomy, fundoplication, colostomy, or other digestive system surgeries; (3) Persistent vomiting or suspected gastrointestinal obstruction; (4) Neuropathy caused by other reasons, such as osteoarthritis, cervical and lumbar spine diseases, connective tissue diseases, peripheral vascular diseases, paraneoplastic peripheral neuropathy, herpes zoster infection, thyroid dysfunction, or severe malnutrition; (5) Use of drugs that may cause peripheral neuropathy, such as isoniazid or furazolidone; (6) Any other clinically significant or unstable mental illness or epilepsy; (7) Severe infections or inflammatory diseases; (8) Severe cardiovascular and cerebrovascular diseases or diseases of the liver, kidneys, and hematopoietic system; (9) Excessive alcohol consumption (more than 5 times a week, more than 100 grams of spirits, 250 grams of yellow wine, or 5 bottles of beer); (10) History of drug abuse or substance misuse; (11) Pregnancy; (12) Inability to clearly recall and follow-up assessments due to other reasons, such as dementia, severe hearing loss, aphasia, etc.; (13) Participation in other intervention trials that may affect the results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gut Microbiota Analysis;Microbial Metabolites; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain Score;Peripheral Neuropathy Score;Neurological Functional Status;Blood Biochemical Indicators;Inflammatory Cytokines; | — |
Countries
China
Contacts
The First Affiliated Hospital of Xi'an Jiaotong University