The Effect of Related Blood Markers on Diabetic Peripheral Neuropathy

Wenzhou Medical University

Status and phase: Enrolling; Phase 4

Conditions: Diabetic Peripheral Neuropathy

Treatments: Drug: hypoglycemic Agents(metformin); Drug: lipid-lowering drug(Statin)

Study type: Interventional

Funder types: Other

Identifiers

NCT06041399

Dbinbin

Details and patient eligibility

About

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

Full 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).

Enrollment: 1,400 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,400 participants in 4 patient groups

diabetic peripheral neuropathy group with hypoglycemic or lipid-lowering drugs.

Experimental group

Description:

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.

Treatment:

Drug: lipid-lowering drug(Statin)

Drug: hypoglycemic Agents(metformin)

diabetic peripheral neuropathy group without hypoglycemic or lipid-lowering drugs.

No Intervention group

Description:

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.

Diabetic group with hypoglycemic or lipid-lowering drugs.

Experimental group

Description:

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.

Treatment:

Drug: lipid-lowering drug(Statin)

Drug: hypoglycemic Agents(metformin)

Diabetic group without hypoglycemic or lipid-lowering drugs.

No Intervention group

Description:

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.