The Effect of Related Blood Markers on Diabetic Peripheral Neuropathy

NCT06041412 | Unknown

• 1 other identifier: DPN
• Study Type: observational
• Target: 1,400
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetic Peripheral Neuropathy

Keywords

Diabetic Peripheral Neuropathy; electromyography; blood parameters

Outcome Measures

Primary Outcomes (2)

• 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.

  From admission to discharge, up to 1 week

• 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.

  From admission to discharge, up to 1 week

Study Arms (3)

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

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• patients who had undergone nerve conduction examination by electromyography.

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

Central Study Contacts

Binbin Deng

CONTACT

dbinbin@aliyun.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2022
• First Posted: September 18, 2023
• Study Start: February 1, 2012
• Primary Completion: December 18, 2022
• Study Completion: January 2, 2025
• Last Updated: September 18, 2023

Record last verified: 2023-08

Locations

CN (1)