The Effect of Related Blood Markers on Diabetic Peripheral Neuropathy

Diabetic Peripheral Neuropathy Clinical Trial

Official title:

The Effect of Related Blood Markers on Diabetic Peripheral Neuropathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06041399
• Other study ID #: Dbinbin
• Status: Recruiting
• Phase: Phase 4
• Start date: February 1, 2012
• Est. completion date: January 2, 2025

Study information

• Verified date: August 2023
• Source: First Affiliated Hospital of Wenzhou Medical University
• Contact: Binbin Deng, Doctor
• Phone: 86-13695720610
• Email: dbinbin[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This is a multi-center(about five), randomized, double-blind, placebo-controlled clinical trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1400
• Est. completion date: January 2, 2025
• Est. primary completion date: December 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients who had undergone nerve conduction examination by electromyography(EMG).

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

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Drug:
• hypoglycemic Agents(metformin)
patients treated with hypoglycemic Agents(metformin)
• lipid-lowering drug(Statin)
patients treated with lipid-lowering drug(Statin)

Locations

Country	Name	City	State
China	First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the severity of diabetic peripheral neuropathy	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
Primary	the presence of diabetic peripheral neuropathy	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 diabetic peripheral neuropathy diagnosis by a specialist.	From admission to discharge, up to 1 week