The Effect of Related Blood Markers on Diabetic Peripheral Neuropathy

Sponsor
First Affiliated Hospital of Wenzhou Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06041412
Collaborator
(none)
1,400
1
155
9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This is a multicenter study(approximately four) 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

    Study Type:
    Observational
    Anticipated Enrollment :
    1400 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    The Effect of Related Blood Markers on Diabetic Peripheral Neuropathy
    Actual Study Start Date :
    Feb 1, 2012
    Actual Primary Completion Date :
    Dec 18, 2022
    Anticipated Study Completion Date :
    Jan 2, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    DPN group

    Patients with type 2 diabetic peripheral neuropathy were categorized into the DPN group

    Diabetic group

    patients with type 2 diabetes mellitus but not with DPN were distributed into the Diabetic group.

    control group

    The other individuals without type 2 diabetes mellitus were selected as the control group

    Outcome Measures

    Primary Outcome Measures

    1. the severity of DPN [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 DPN [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 DPN diagnosis by a specialist.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • patients who had undergone nerve conduction examination by electromyography.
    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

    Locations

    Site City State Country Postal Code
    1 First Affiliated Hospital of Wenzhou Medical University Wenzhou Zhejiang China 325000

    Sponsors and Collaborators

    • First Affiliated Hospital of Wenzhou Medical University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    First Affiliated Hospital of Wenzhou Medical University
    ClinicalTrials.gov Identifier:
    NCT06041412
    Other Study ID Numbers:
    • DPN
    First Posted:
    Sep 18, 2023
    Last Update Posted:
    Sep 18, 2023
    Last Verified:
    Aug 1, 2023
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 18, 2023