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RecruitingNCT06041412Updated Sep 18, 2023

The Effect of Related Blood Markers on Diabetic Peripheral Neuropathy

An observational study in Diabetic Peripheral Neuropathy, sponsored by First Affiliated Hospital of Wenzhou Medical University. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2023-09-18.

Sponsored by First Affiliated Hospital of Wenzhou Medical University · Observational

From the registry’s dates

  • Started Feb 2012; still recruiting 14 years 8 months later.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
1,400
Sex
All
01

Study summary

The goal of this observational study is to explore the relationship between related blood indicators and diabetic peripheral neuropathy(DPN).

Read the detailed description

This is a multicenter study(approximately four) with over 1000 subjects.Clinical data were collected by consulting the patient's electronic history. The data included demographic information, blood biochemical markers and electromyography. All participants provided their written informed consent to participate in this study.The study protocol was approved by the Ethics Committee of the First Affiliated Hospital of Wenzhou Medical University(KY-2022-R009).

02

Conditions studied

  • Diabetic Peripheral Neuropathy

Keywords

  • Diabetic Peripheral Neuropathy
  • electromyography
  • blood parameters
03

In context

Peripheral Nervous System Diseases

1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.

This study's planned enrollment of 1,400 is above the median of 90 across 188 observational studies indexed under Peripheral Nervous System Diseases.

Browse Peripheral Nervous System Diseases studies →

Lead sponsor

First Affiliated Hospital of Wenzhou Medical University is the lead sponsor of 82 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Sampling method
Probability sample

Study population

This is a multicenter study(approximately four) with over 1000 subjects.Clinical data were collected by consulting the patient's electronic history. The data included demographic information, blood biochemical markers and electromyography. All participants provided their written informed consent to participate in this study.

Inclusion criteria

  • patients who had undergone nerve conduction examination by electromyography.

Exclusion criteria

Exclusion Criteria:

  • pregnancy and lactation; chronic liver disease, kidney disease, arrhythmias, malignant diseases, severe respiratory diseases, heart failure, and acute infections;
  • patients with alcohol abuse; history of Autoimmune liver disease, liver disease or abnormal liver function at baseline;
  • parathyroid diseases (including hyperthyroidism and hypothyroidism);
  • pancreatitis, pancreatectomy or any transplant;
  • patients with malignancy and any serious concomitant disease limit the existence of life expectancy
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
1,400 participants (estimated)
Patient registry
No

Groups and cohorts

  • DPN group

    Patients with type 2 diabetic peripheral neuropathy were categorized into the DPN group

  • Diabetic group

    patients with type 2 diabetes mellitus but not with DPN were distributed into the Diabetic group.

  • control group

    The other individuals without type 2 diabetes mellitus were selected as the control group

06

What researchers measure

Primary outcomes

  1. the severity of DPN

    The nerve conduction examination was conducted at a room temperature of 24℃, with the legs warmed using an electric heating pad for at least 10 minutes to achieve a skin temperature of 32-35℃. The nerve conduction velocities and nerve conduction amplitudes were measured for both sides of the upper and lower limbs, including motor and sensory branches of the median nerve; motor and sensory branches of the ulnar nerve; motor branch of peroneal nerve; motor branch of the tibial nerve; sensory branch of the superficial peroneal nerve. In addition, both sides of the tibial nerve F-wave were recorded, and the lower one was regarded as the final F-wave. Slowed/blocked nerve conduction was defined as more than 2.5 standard deviation below the control nerve conduction threshold. Nerve conduction is defined as abnormal when two or more nerve abnormalities are detected.

    Time frame: From admission to discharge, up to 1 week

  2. the presence of DPN

    When any of the elements of the screening process -- symptoms, signs, or abnormal nerve conduction parameters --was abnormal, medical records would be scrutinized to see if these participants had accepted a previous DPN diagnosis by a specialist.

    Time frame: From admission to discharge, up to 1 week

07

Study locations

1 of 1 sites recruiting
  • First Affiliated Hospital of Wenzhou Medical University
    Wenzhou, Zhejiang 325000, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06041412
Lead sponsor
First Affiliated Hospital of Wenzhou Medical University
Responsible party
Sponsor
First posted
Sep 18, 2023
Start date
Feb 1, 2012
Primary completion
Dec 18, 2022
Completion
Jan 2, 2025 (estimated)
Last update
Sep 18, 2023

Study contacts

Binbin Deng
Contact
dbinbin@aliyun.com

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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