- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06041412
The Effect of Related Blood Markers on Diabetic Peripheral Neuropathy
September 11, 2023 updated by: First Affiliated Hospital of Wenzhou Medical University
The goal of this observational study is to explore the relationship between related blood indicators and diabetic peripheral neuropathy(DPN).
Study Overview
Status
Recruiting
Conditions
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 Type
Observational
Enrollment (Estimated)
1400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Binbin Deng
- Phone Number: dbinbin@aliyun.com
Study Locations
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Zhejiang
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Wenzhou, Zhejiang, China, 325000
- Recruiting
- First Affiliated Hospital of Wenzhou Medical University
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Contact:
- Binbin Deng, Doctor
- Phone Number: +8613695720610
- Email: dbinbin@aliyun.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
Study Population
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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DPN group
Patients with type 2 diabetic peripheral neuropathy were categorized into the DPN group
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Diabetic group
patients with type 2 diabetes mellitus but not with DPN were distributed into the Diabetic group.
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control group
The other individuals without type 2 diabetes mellitus were selected as the control group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the severity of DPN
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.
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From admission to discharge, up to 1 week
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the presence of DPN
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 DPN diagnosis by a specialist.
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From admission to discharge, up to 1 week
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2012
Primary Completion (Actual)
December 18, 2022
Study Completion (Estimated)
January 2, 2025
Study Registration Dates
First Submitted
December 26, 2022
First Submitted That Met QC Criteria
September 11, 2023
First Posted (Actual)
September 18, 2023
Study Record Updates
Last Update Posted (Actual)
September 18, 2023
Last Update Submitted That Met QC Criteria
September 11, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DPN
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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