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The Effect of Related Blood Markers on Diabetic Peripheral Neuropathy

Primary Purpose

Diabetic Peripheral Neuropathy

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
hypoglycemic Agents(metformin)
lipid-lowering drug(Statin)
Sponsored by
First Affiliated Hospital of Wenzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetic Peripheral Neuropathy focused on measuring Diabetic Peripheral Neuropathy, electromyography, blood parameters

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • First Affiliated Hospital of Wenzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Arm Label

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

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

Diabetic group with hypoglycemic or lipid-lowering drugs.

Diabetic group without hypoglycemic or lipid-lowering drugs.

Arm 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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 26, 2022
Last Updated
September 11, 2023
Sponsor
First Affiliated Hospital of Wenzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT06041399
Brief Title
The Effect of Related Blood Markers on Diabetic Peripheral Neuropathy
Official Title
The Effect of Related Blood Markers on Diabetic Peripheral Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2012 (Actual)
Primary Completion Date
December 18, 2022 (Actual)
Study Completion Date
January 2, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital of Wenzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Peripheral Neuropathy
Keywords
Diabetic Peripheral Neuropathy, electromyography, blood parameters

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
1400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
diabetic peripheral neuropathy group with hypoglycemic or lipid-lowering drugs.
Arm Type
Experimental
Arm 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.
Arm Title
diabetic peripheral neuropathy group without hypoglycemic or lipid-lowering drugs.
Arm Type
No Intervention
Arm 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.
Arm Title
Diabetic group with hypoglycemic or lipid-lowering drugs.
Arm Type
Experimental
Arm 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.
Arm Title
Diabetic group without hypoglycemic or lipid-lowering drugs.
Arm Type
No Intervention
Arm 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.
Intervention Type
Drug
Intervention Name(s)
hypoglycemic Agents(metformin)
Intervention Description
patients treated with hypoglycemic Agents(metformin)
Intervention Type
Drug
Intervention Name(s)
lipid-lowering drug(Statin)
Intervention Description
patients treated with lipid-lowering drug(Statin)
Primary Outcome Measure Information:
Title
the severity of diabetic peripheral neuropathy
Description
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
Title
the presence of diabetic peripheral neuropathy
Description
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Binbin Deng, Doctor
Phone
86-13695720610
Email
dbinbin@aliyun.com
Facility Information:
Facility Name
First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Binbin Deng, Doctor
Phone
+8613695720610
Email
dbinbin@aliyun.com

12. IPD Sharing Statement

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The Effect of Related Blood Markers on Diabetic Peripheral Neuropathy

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