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Clinical Trials/NCT06041412
NCT06041412
Recruiting
Not Applicable

The Effect of Related Blood Markers on Diabetic Peripheral Neuropathy

First Affiliated Hospital of Wenzhou Medical University1 site in 1 country1,400 target enrollmentFebruary 1, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetic Peripheral Neuropathy
Sponsor
First Affiliated Hospital of Wenzhou Medical University
Enrollment
1400
Locations
1
Primary Endpoint
the presence of DPN
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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

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).

Registry
clinicaltrials.gov
Start Date
February 1, 2012
End Date
January 2, 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • patients who had undergone nerve conduction examination by electromyography.

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

Outcomes

Primary Outcomes

the presence of DPN

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

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.

the severity of DPN

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

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.

Study Sites (1)

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