The Effect of Related Blood Markers on Diabetic Peripheral Neuropathy

First Affiliated Hospital of Wenzhou Medical University1,400 enrolled

Overview

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

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

1,400

Conditions

Diabetic Peripheral Neuropathy

Interventions

hypoglycemic Agents(metformin)DRUG

patients treated with hypoglycemic Agents(metformin)

lipid-lowering drug(Statin)DRUG

patients treated with lipid-lowering drug(Statin)

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

RECRUITING

Outcomes

Primary Outcomes

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.

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

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.

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

Central Contacts

Binbin Deng, Doctor

CONTACT

86-13695720610 dbinbin@aliyun.com

Data from ClinicalTrials.gov

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