The Effect of Related Blood Markers on Diabetic Peripheral Neuropathy

NCT ID: NCT06041399

Last Updated: 2023-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

1400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-01

Study Completion Date

2025-01-02

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).

Conditions

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Diabetic Peripheral Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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

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.

Group Type EXPERIMENTAL

hypoglycemic Agents(metformin)

Intervention Type DRUG

patients treated with hypoglycemic Agents(metformin)

lipid-lowering drug(Statin)

Intervention Type DRUG

patients treated with lipid-lowering drug(Statin)

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Diabetic group with hypoglycemic or lipid-lowering drugs.

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.

Group Type EXPERIMENTAL

hypoglycemic Agents(metformin)

Intervention Type DRUG

patients treated with hypoglycemic Agents(metformin)

lipid-lowering drug(Statin)

Intervention Type DRUG

patients treated with lipid-lowering drug(Statin)

Diabetic group without hypoglycemic or lipid-lowering drugs.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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hypoglycemic Agents(metformin)

patients treated with hypoglycemic Agents(metformin)

Intervention Type DRUG

lipid-lowering drug(Statin)

patients treated with lipid-lowering drug(Statin)

Intervention Type DRUG

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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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First Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Binbin Deng, Doctor

Role: CONTACT

86-13695720610

Facility Contacts

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Binbin Deng, Doctor

Role: primary

+8613695720610

Other Identifiers

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Dbinbin

Identifier Type: -

Identifier Source: org_study_id

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