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Association of 2,5-hexanedione with distal symmetrical polyneuropathy and cardiac autonomic neuropathy in diabetic patients

Association of 2,5-hexanedione with distal symmetrical polyneuropathy and cardiac autonomic neuropathy in diabetic patients

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100045956
Enrollment
Unknown
Registered
2021-04-30
Start date
2021-05-06
Completion date
Unknown
Last updated
2021-12-13

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

Conditions

Diabetic peripheral neuropathy

Interventions

DSPN-hyperglycaemic group:No intervention
DSPN-normal group:No intervention
CAN-hyperglycaemic group:No intervention
CAN-normal group:No intervention
DM non DPN-hyperglycaemic group:No intervention
DM non DPN-normal group:No intervention

Sponsors

Shenzhen People Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged 45 to 60 years. 2. DM non-DPN group: Patients with confirmed type 2 diabetes who do not meet the DSPN confirmatory criteria or CAN diagnostic criteria. 3. DPN group: Patients with confirmed type 2 diabetes who meet the DSPN confirmatory criteria or CAN diagnostic criteria. 4. Normal/hyperglycaemic group: grouped according to glycated haemoglobin level, defining HbA1c >= 9% as hyperglycaemic group and HbA1c < 9% as relatively normal blood glucose group. 5. Healthy control group: non-diabetic or pre-diabetic patients with normal nerve conduction function.

Exclusion criteria

Exclusion criteria: 1. The existence of acquired non-specific inflammatory demyelinating peripheral neuropathy, including but not limited to: Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy, etc.; 2. Peripheral neuropathy caused by other systemic diseases, including but not limited to: renal failure (eGFR<30ml/(min*1.73m2)), liver failure or cirrhosis, excessive alcoholism, tumor, abnormal thyroid function, connective tissue Sexual diseases, severe anemia or malnutrition, unstable conditions of various reasons, HIV infection; 3. There are situations that are not suitable for nerve conduction examinations temporarily, including but not limited to: diabetic foot, gout, foot osteoarthritis, high skin temperature/low body temperature caused by fever, severe lower limb vascular disease, mental anxiety or related mental illness Sexual diseases, lower extremity edema; 4. Pregnancy; 5. Take aldose reduction inhibitors, diuretics, vasodilators, tricyclic antidepressants, etc. including epalrestat; 6. Urobilinogen is positive; 7. Other types of heart disease and arrhythmia; 8. Unable to participate in research due to other reasons.

Design outcomes

Primary

MeasureTime frame
DSPN assessment;CAN assessment;Pyrrole adduct level;

Secondary

MeasureTime frame
Spectrin level;Indicators of axonal neuropathy;

Countries

China

Contacts

Public ContactWu Yan

Shenzhen People Hospital

chenxiao@szcdc.net+86 13802230166

Outcome results

None listed

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