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The Effect of Related Blood Markers on Diabetic Peripheral Neuropathy

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ClinicalTrials.gov Identifier: NCT06041399
Recruitment Status : Recruiting
First Posted : September 18, 2023
Last Update Posted : September 18, 2023
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital of Wenzhou Medical University

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

Condition or disease Intervention/treatment Phase
Diabetic Peripheral Neuropathy Drug: hypoglycemic Agents(metformin) Drug: lipid-lowering drug(Statin) Phase 4

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: The Effect of Related Blood Markers on Diabetic Peripheral Neuropathy
Actual Study Start Date : February 1, 2012
Actual Primary Completion Date : December 18, 2022
Estimated Study Completion Date : January 2, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: hypoglycemic Agents(metformin)
patients treated with hypoglycemic Agents(metformin)

Drug: lipid-lowering drug(Statin)
patients treated with lipid-lowering drug(Statin)
No Intervention: 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.
Experimental: 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.
 Drug: hypoglycemic Agents(metformin)
patients treated with hypoglycemic Agents(metformin)

Drug: lipid-lowering drug(Statin)
patients treated with lipid-lowering drug(Statin)
No Intervention: 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.


Outcome Measures
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Primary Outcome Measures :
  1. the severity of diabetic peripheral neuropathy [ Time Frame: From admission to discharge, up to 1 week ]
    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.

  2. the presence of diabetic peripheral neuropathy [ Time Frame: From admission to discharge, up to 1 week ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06041399


Contacts
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Contact: Binbin Deng, Doctor 86-13695720610 dbinbin@aliyun.com

Locations
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China, Zhejiang
First Affiliated Hospital of Wenzhou Medical University Recruiting
Wenzhou, Zhejiang, China, 325000
Contact: Binbin Deng, Doctor    +8613695720610    dbinbin@aliyun.com   
Sponsors and Collaborators
First Affiliated Hospital of Wenzhou Medical University
More Information
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Responsible Party: First Affiliated Hospital of Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT06041399    
Other Study ID Numbers: Dbinbin
First Posted: September 18, 2023    Key Record Dates
Last Update Posted: September 18, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by First Affiliated Hospital of Wenzhou Medical University:
Diabetic Peripheral Neuropathy
electromyography
blood parameters
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
 Metformin
Hypoglycemic Agents
Hypolipidemic Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents