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Magnetic resonance structure and functional imaging of lower limb neuropathy in type 2 diabetes mellitus

Magnetic resonance structure and functional imaging of lower limb neuropathy in type 2 diabetes mellitus

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300075147
Enrollment
Unknown
Registered
2023-08-28
Start date
2023-01-01
Completion date
Unknown
Last updated
2023-09-04

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

Conditions

Diabetic peripheral neuropathy

Interventions

Diabetic peripheral neuropathy patients:None
Ordinary diabetic patients:None

Sponsors

Affiliated Hospital of Zunyi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Inclusion criteria of healthy volunteers: ? age > 18 years old, ? cooperation with magnetic resonance examination. 2. Inclusion criteria of common diabetic patients: The diagnosis of diabetes is mainly based on the 1999 WHO diagnostic criteria for diabetes, that is, one of the following three conditions plus diabetic symptoms (such as typical "three more and one less" symptoms): ? Random blood sugar > 11.1 mmol/L; ? Fasting blood glucose > 7.0mmol/L; ? OGTT 2-hour blood glucose (glucose tolerance test > 11.1 mmol/L). If the examinee has no obvious symptoms of diabetes, it needs another day to check and verify for a definite diagnosis. 3. Inclusion criteria of diabetic peripheral neuropathy patients: DPN patients are diagnosed according to the positive results of NCS and the positive symptoms or signs of neuropathy. Patients with negative NCS results and negative symptoms and signs are considered as DPN-free. The clinical standard of DPN requires the presence of more than one symptom (numbness, tingling, weakness, foot pain and ataxia) or signs (abnormal knee or ankle reflexes and temperature, light contact, monofilament or vibration) that conform to the pattern of distal symmetric neuropathy. If NCS is positive and clinical symptoms or signs are positive, they will be included in DPN group; otherwise, they will be diagnosed as possible DPN and excluded. NCS was negative and clinical symptoms or signs were negative, so they were included in the non-DPN group.

Exclusion criteria

Exclusion criteria: 1. The exclusion criteria of healthy volunteers were as follows: ?pregnancy ?suffered from systemic nervous system diseases, post-traumatic changes, nerve entrapment syndrome, musculoskeletal diseases or systemic metabolic diseases that may lead to peripheral nerve abnormalities ? local inflammation, trauma, scar, tumor or surgical history in the control area. ?any history of lumbar surgery or disc herniation, any contraindication of MR imaging. 2. Exclusion criteria for patients with general diabetes: ?T1DM ? known history of polyneuropathy caused by other causes, such as heredity; alcohol, metabolic abatement, disruption of inflammation, cervical and lumbar spine disease, demyelination or toxic factors; ? skin lesions or swelling that interfere with nerve conduction; cerebral infarction and other central nervous system diseases; ? and known history of leg or ankle fractures or operations, any history of lumbar surgery or disc herniation, any contraindications for MR imaging. 3. Patients with diabetic peripheral neuropathy were excluded from diagnosis: ? known history of polyneuropathy caused by other causes (such as genetic, alcohol, metabolic, inflammatory or toxic factors); ? any history of lumbar surgery or disc herniation, any contraindications for MR imaging; ? known history of leg or ankle fractures or surgery. ? participants in the control group with type 2 diabetes were also excluded.

Design outcomes

Primary

MeasureTime frame
Fractional anisotropy;Nerve perimeter;

Secondary

MeasureTime frame
Nerve cross-sectional area;

Countries

China

Contacts

Public ContactYanji Zhang; Dali wang

Affiliated Hospital of Zunyi Medical University

754290854@qq.com+86 185 2450 7852

Outcome results

None listed

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