Diabetic Peripheral NeuropathyPhase 4NCT06041399
The Effect of Related Blood Markers on Diabetic Peripheral Neuropathy
A Phase 4 study testing hypoglycemic Agents(metformin) and lipid-lowering drug(Statin) in people with Diabetic Peripheral Neuropathy, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
The goal of this observational study is to explore the relationship between related blood indicators and diabetic peripheral neuropathy. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- hypoglycemic Agents(metformin) and lipid-lowering drug(Statin)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2012to 2 Jan 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- patients who had undergone nerve conduction examination by electromyography(EMG).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Binbin Deng, Doctor, +8613695720610, dbinbin@aliyun.com
About this study
The goal of this observational study is to explore the relationship between related blood indicators and diabetic peripheral neuropathy.
Read the 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).
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- hypoglycemic Agents(metformin), lipid-lowering drug(Statin)
- Keywords
- Diabetic Peripheral Neuropathy, electromyography, blood parameters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypoglycemic Agents(metformin)Drug
patients treated with hypoglycemic Agents(metformin)
lipid-lowering drug(Statin)Drug
patients treated with lipid-lowering drug(Statin)
| Study group | Role | What they receive |
|---|---|---|
| diabetic peripheral neuropathy group with hypoglycemic or lipid-lowering drugs. | Experimental | 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. Receives: Drug: hypoglycemic Agents(metformin); Drug: lipid-lowering drug(Statin) |
| diabetic peripheral neuropathy group without hypoglycemic or lipid-lowering drugs. | No intervention | 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. |
| Diabetic group with hypoglycemic or lipid-lowering drugs. | Experimental | 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. Receives: Drug: hypoglycemic Agents(metformin); Drug: lipid-lowering drug(Statin) |
| Diabetic group without hypoglycemic or lipid-lowering drugs. | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From admission to discharge, up to 1 week
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.
Measured: From admission to discharge, up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start1 Feb 2012
- Primary completion18 Dec 2022
- Study completion2 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06041399
- Sponsor's protocol ID
- Dbinbin
- Status last verified
- Aug 2023
- First submitted
- 26 Dec 2022
- Last updated
- 18 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Related Blood Markers on Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT06041399
- Acronym / sponsor ID
- Dbinbin
- Conditions
- Diabetic Peripheral Neuropathy
- Keywords
- Diabetic Peripheral Neuropathy, electromyography, blood parameters
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2012 (actual)
- Primary completion
- 18 Dec 2022 (actual)
- Study completion
- 2 Jan 2025 (estimated)
- First posted
- 18 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| diabetic peripheral neuropathy group with hypoglycemic or lipid-lowering drugs. | Experimental | Drug: hypoglycemic Agents(metformin), Drug: lipid-lowering drug(Statin)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. |
| diabetic peripheral neuropathy group without hypoglycemic or lipid-lowering drugs. | No intervention | –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. |
| Diabetic group with hypoglycemic or lipid-lowering drugs. | Experimental | Drug: hypoglycemic Agents(metformin), Drug: lipid-lowering drug(Statin)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. |
| Diabetic group without hypoglycemic or lipid-lowering drugs. | No intervention | –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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients who had undergone nerve conduction examination by electromyography(EMG).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hypoglycemic Agents(metformin)patients treated with hypoglycemic Agents(metformin) | Drug | Diabetic group with hypoglycemic or lipid-lowering drugs., diabetic peripheral neuropathy group with hypoglycemic or lipid-lowering drugs. |
| lipid-lowering drug(Statin)patients treated with lipid-lowering drug(Statin) | Drug | Diabetic group with hypoglycemic or lipid-lowering drugs., diabetic peripheral neuropathy group with hypoglycemic or lipid-lowering drugs. |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing hypoglycemic Agents(metformin) and lipid-lowering drug(Statin) in people with Diabetic Peripheral Neuropathy, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Binbin Deng, Doctor (86-13695720610, dbinbin@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the severity of diabetic peripheral neuropathy (time frame: From admission to discharge, up to 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.