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Relevant Research on the Gut Microbiota and the Occurrence and Development of Diabetes and Its Complications

Study on the Mechanism of Gut Microbiota Affecting Diabetic Peripheral Neuropathy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400092757
Enrollment
Unknown
Registered
2024-11-22
Start date
2024-12-01
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Peripheral Neuropathy

Interventions

Normal control group:none
Diabetes without Peripheral Neuropathy Group:none
Diabetes with Peripheral Neuropathy Group:none

Sponsors

The First Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 70 Years

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

MeasureTime frame
Gut Microbiota Analysis;Microbial Metabolites;

Secondary

MeasureTime frame
Pain Score;Peripheral Neuropathy Score;Neurological Functional Status;Blood Biochemical Indicators;Inflammatory Cytokines;

Countries

China

Contacts

Public ContactXin Shen

The First Affiliated Hospital of Xi'an Jiaotong University

398018271@qq.com+86 159 0290 8060

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026