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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06041399
Other study ID # Dbinbin
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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