Painful Diabetic NeuropathyNCT03700502
Functional Magnetic Resonance Imaging of Brain Activity in Patients With Painful Diabetic Neuropathy
An observational study of Painful Diabetic Neuropathy, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
Patients with painful diabetic neuropathy (PDN) often combine with anxiety and depression. However, the pathogenesis of PDN is unclear, especially the mechanism associated with central nervous system. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Painful Diabetic Neuropathy
- What is being tested?
- resting-state functional Magnetic Resonance Imaging
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 5 Jun 2016to Nov 2018
- Phase
- Observational
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Meet the diagnosis of diabetic peripheral neuropathy (at the same time meets the following three items, of which painful neuropathy patients have pain symptom): (1) neuropathy occurs not earlier than the diagnosis of diabetes; (2) having clinical manifestations of pain, numbness, and abnormal sensation; (3) any abnormality in the following 5 examinations: ankle reflex, vibratory sensation, pressure sensation, temperature sensation, and acupuncture pain.
Who may be able to join
- Voluntary participation and signing informed consent
- 18 to 60 years old with junior high school education or above
- meeting the 1999 WHO type 2 diabetes diagnostic criteria: having symptoms of diabetes (polydipsia, polyphagia, polyuria and unexplained weight loss) plus one of the following 3 items: (1) random blood glucose more than 11.1 mmol/L; (2) fasting blood glucose more than 7 mmol/L; (3) after 2 hours glucose load, the blood sugar more than 11.1 mmol/L
- The diagnosis of diabetic peripheral neuropathy (at the same time meets the following three items, of which painful neuropathy patients have pain symptom): (1) neuropathy occurs not earlier than the diagnosis of diabetes; (2) having clinical manifestations of pain, numbness, and abnormal sensation; (3) any abnormality in the following 5 examinations: ankle reflex, vibratory sensation, pressure sensation, temperature sensation, and acupuncture pain
Who cannot join
- left-hand writers
- neuropathy caused by other causes, such as cervical spondylosis, cerebral infarction, Green Barre syndrome; severe arteriovenous disease; neurotoxic changes caused by drugs and renal insufficiency
- patients with severe cerebral vascular disease
- diagnosed mental disorders such as depression, anxiety and Alzheimer's disease
- patients who can't accept head magnetic resonance imaging, such as those with metal (stents, metal dentures, internal fixation plates, etc.), and claustrophobic space phobias
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the first hospital of Nanjing
Nanjing, Jiangsu, 210006
Jin Dan Wu, master, 0086-18951670336, wujindandan@sina.com
Qing Zhang, master, 0086-15950522889, zhangqingwork@sina.com
About this study
Official title: Use Resting-state Functional Magnetic Resonance Imaging (Rs-fMRI) to Explore the Brain Activity in Patients With Painful Diabetic Neuropathy (PDN) in Order to Study Central Mechanism of PDN.
Patients with painful diabetic neuropathy (PDN) often combine with anxiety and depression. However, the pathogenesis of PDN is unclear, especially the mechanism associated with central nervous system. The investigators used fraction Amplitude of Low Frequency Fluctuation (fALFF) and Regional Homogeneity (ReHo) of resting-state functional Magnetic Resonance Imaging (rs-fMRI) to explore the brain activity in patients with PDN in order to study the central mechanism.The investigators evaluated the symptoms, signs and mental conditions of patients with PDN and non-pain neuropathy. The brain Blood Oxygen Level Dependent (BOLD) fMRI scan was performed in patients together with some gender and age matched healthy controls. Maybe this study can find that patients with PDN have abnormal brain activity, indicating central nervous system may contribute to painful diabetic neuropathy.
- Conditions
- Painful Diabetic Neuropathy
- Being tested
- resting-state functional Magnetic Resonance Imaging
- Keywords
- resting state functional MRI, painful diabetic neuropathy
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resting-state functional Magnetic Resonance ImagingDiagnostic test
The investigators used fraction Amplitude of Low Frequency Fluctuation (fALFF) and Regional Homogeneity (ReHo) of resting-state functional Magnetic Resonance Imaging (rs-fMRI) to explore the brain activity in patients with PDN in order to study the central mechanism. The investigators also evaluated the symptoms, signs and mental conditions of the patients.
| Study group | Role | What they receive |
|---|---|---|
| patients with painful diabetic neuropathy | Not described Receives: Diagnostic Test: resting-state functional Magnetic Resonance Imaging | |
| diabetics with non-pain neuropathy | Not described Receives: Diagnostic Test: resting-state functional Magnetic Resonance Imaging | |
| gender and age matched healthy controls | Not described Receives: Diagnostic Test: resting-state functional Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
resting-state functional Magnetic Resonance Imaging
collect and analyze the data of brain fMRI
Measured: one or two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start5 Jun 2016
- Primary completionNov 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Painful Diabetic NeuropathyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Province Nanjing Brain Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700502
- Sponsor's protocol ID
- 201605027
- Status last verified
- Mar 2018
- First submitted
- 27 Sep 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Liu X, Xu X, Mao C, Zhang P, Zhang Q, Jiang L, Yang Y, Ma J, Ye L, Lee KO, Wu J, Yao Z. Increased thalamo-cortical functional connectivity in patients with diabetic painful neuropathy: A resting-state functional MRI study. Exp Ther Med. 2021 May;21(5):509. doi: 10.3892/etm.2021.9940. Epub 2021 Mar 19.
PubMed 33791018Zhang Q, Zhang P, Yan R, Xu X, Mao C, Liu X, Li F, Ma J, Ye L, Yao Z, Wu J. A Single-Blinded Trial Using Resting-State Functional Magnetic Resonance Imaging of Brain Activity in Patients with Type 2 Diabetes and Painful Neuropathy. Diabetes Ther. 2019 Feb;10(1):135-147. doi: 10.1007/s13300-018-0534-x. Epub 2018 Nov 30.
PubMed 30506341
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use Resting-state Functional Magnetic Resonance Imaging (Rs-fMRI) to Explore the Brain Activity in Patients With Painful Diabetic Neuropathy (PDN) in Order to Study Central Mechanism of PDN.
- ClinicalTrials.gov ID
- NCT03700502
- Acronym / sponsor ID
- 201605027
- Conditions
- Painful Diabetic Neuropathy
- Keywords
- resting state functional MRI, painful diabetic neuropathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Jiangsu Province Nanjing Brain Hospital
- Study start
- 5 Jun 2016 (actual)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 9 Oct 2018 (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.
Patients with painful diabetic neuropathy (PDN) often combine with anxiety and depression. However, the pathogenesis of PDN is unclear, especially the mechanism associated with central nervous system. The investigators used fraction Amplitude of Low Frequency Fluctuation (fALFF) and Regional Homogeneity (ReHo) of resting-state functional Magnetic Resonance Imaging (rs-fMRI) to explore the brain activity in patients with PDN in order to study the central mechanism.The investigators evaluated the symptoms, signs and mental conditions of patients with PDN and non-pain neuropathy. The brain Blood Oxygen Level Dependent (BOLD) fMRI scan was performed in patients together with some gender and age matched healthy controls. Maybe this study can find that patients with PDN have abnormal brain activity, indicating central nervous system may contribute to painful diabetic neuropathy.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patients with painful diabetic neuropathy | – | Diagnostic Test: resting-state functional Magnetic Resonance Imaging |
| diabetics with non-pain neuropathy | – | Diagnostic Test: resting-state functional Magnetic Resonance Imaging |
| gender and age matched healthy controls | – | Diagnostic Test: resting-state functional Magnetic Resonance Imaging |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Meet the diagnosis of diabetic peripheral neuropathy (at the same time meets the following three items, of which painful neuropathy patients have pain symptom): (1) neuropathy occurs not earlier than the diagnosis of diabetes; (2) having clinical manifestations of pain, numbness, and abnormal sensation; (3) any abnormality in the following 5 examinations: ankle reflex, vibratory sensation, pressure sensation, temperature sensation, and acupuncture pain.
Key inclusion criteria (4 listed)
- Voluntary participation and signing informed consent
- 18 to 60 years old with junior high school education or above
- meeting the 1999 WHO type 2 diabetes diagnostic criteria: having symptoms of diabetes (polydipsia, polyphagia, polyuria and unexplained weight loss) plus one of the following 3 items: (1) random blood glucose more than 11.1 mmol/L; (2) fasting blood glucose more than 7 mmol/L; (3) after 2 hours glucose load, the blood sugar more than 11.1 mmol/L
- The diagnosis of diabetic peripheral neuropathy (at the same time meets the following three items, of which painful neuropathy patients have pain symptom): (1) neuropathy occurs not earlier than the diagnosis of diabetes; (2) having clinical manifestations of pain, numbness, and abnormal sensation; (3) any abnormality in the following 5 examinations: ankle reflex, vibratory sensation, pressure sensation, temperature sensation, and acupuncture pain
Key exclusion criteria (5 listed)
- left-hand writers
- neuropathy caused by other causes, such as cervical spondylosis, cerebral infarction, Green Barre syndrome; severe arteriovenous disease; neurotoxic changes caused by drugs and renal insufficiency
- patients with severe cerebral vascular disease
- diagnosed mental disorders such as depression, anxiety and Alzheimer's disease
- patients who can't accept head magnetic resonance imaging, such as those with metal (stents, metal dentures, internal fixation plates, etc.), and claustrophobic space phobias
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 |
|---|---|---|
| resting-state functional Magnetic Resonance ImagingThe investigators used fraction Amplitude of Low Frequency Fluctuation (fALFF) and Regional Homogeneity (ReHo) of resting-state functional Magnetic Resonance Imaging (rs-fMRI) to explore the brain activity in patients with PDN in order to study the central mechanism. The investigators also evaluated the symptoms, signs and mental conditions of the patients. | Diagnostic test | diabetics with non-pain neuropathy, gender and age matched healthy controls, patients with painful diabetic neuropathy |
Primary outcome
resting-state functional Magnetic Resonance Imaging
Time frame: one or two years
collect and analyze the data of brain fMRI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Derived from this study: PubMed 33791018Liu X, Xu X, Mao C, Zhang P, Zhang Q, Jiang L, Yang Y, Ma J, Ye L, Lee KO, Wu J, Yao Z. Increased thalamo-cortical functional connectivity in patients with diabetic painful neuropathy: A resting-state functional MRI study. Exp Ther Med. 2021 May;21(5):509. doi: 10.3892/etm.2021.9940. Epub 2021 Mar 19.
- Derived from this study: PubMed 30506341Zhang Q, Zhang P, Yan R, Xu X, Mao C, Liu X, Li F, Ma J, Ye L, Yao Z, Wu J. A Single-Blinded Trial Using Resting-State Functional Magnetic Resonance Imaging of Brain Activity in Patients with Type 2 Diabetes and Painful Neuropathy. Diabetes Ther. 2019 Feb;10(1):135-147. doi: 10.1007/s13300-018-0534-x. Epub 2018 Nov 30.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Painful Diabetic Neuropathy, run by Nanjing First Hospital, Nanjing 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 4 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 9 Oct 2018. 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.
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 Jin Dan Wu, master (0086-18951670336, wujindandan@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
resting-state functional Magnetic Resonance Imaging (time frame: one or two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03700502, which also lists 2 linked publications.
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 9 Oct 2018; AzTrials last refreshed its copy on 26 Oct 2026.