The Effect of Related Blood Markers on Diabetic Peripheral Neuropathy

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

Detailed Description
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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).

Official Title
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The Effect of Related Blood Markers on Diabetic Peripheral Neuropathy

Conditions
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Diabetic Peripheral Neuropathy

Intervention / Treatment
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* Drug: hypoglycemic Agents(metformin)
* Drug: lipid-lowering drug(Statin)


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: diabetic peripheral neuropathy group with hypoglycemic or lipid-lowering drugs.<br>Patients with type 2 diabetic peripheral neuropathy were categorized into the diabetic peripheral neuropathy group with hypoglycemic or lipid-lowering drugs group.The group treated with specific drug,like hypoglycemic or lipid-lowering drugs. | Drug: hypoglycemic Agents(metformin)<br>* patients treated with hypoglycemic Agents(metformin)<br>Drug: lipid-lowering drug(Statin)<br>* patients treated with lipid-lowering drug(Statin)<br>|
| No Intervention: diabetic peripheral neuropathy group without hypoglycemic or lipid-lowering drugs.<br>Patients with type 2 diabetic peripheral neuropathy were categorized into the diabetic peripheral neuropathy group without hypoglycemic or lipid-lowering drugs group.No hypoglycemic or lipid-lowering drugs were used in this group. | |
| Experimental: Diabetic group with hypoglycemic or lipid-lowering drugs.<br>Patients with type 2 diabetes mellitus but not with diabetic peripheral neuropathy were distributed into the Diabetic group with hypoglycemic or lipid-lowering drugs group. group.The group treated with specific drug,like hypoglycemic or lipid-lowering drugs. | Drug: hypoglycemic Agents(metformin)<br>* patients treated with hypoglycemic Agents(metformin)<br>Drug: lipid-lowering drug(Statin)<br>* patients treated with lipid-lowering drug(Statin)<br>|
| No Intervention: Diabetic group without hypoglycemic or lipid-lowering drugs.<br>Patients with type 2 diabetes mellitus but not with diabetic peripheral neuropathy were distributed into the Diabetic group without hypoglycemic or lipid-lowering drugs group.No hypoglycemic or lipid-lowering drugs were used in this group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Peripheral Neuropathy, electromyography, blood parameters