Diabetic NeuropathyNCT02606747
The Balance Control Mechanism of DPN Patients
An observational study of Diabetic Neuropathy, run by Geheng Yuan at 1 site in China.
Trial summary
This study will evaluate the balance ability of DPN (diabetic peripheral neuropathy)patients, which will help us to understand the relationship between peripheral and central nervous system, in order to early diagnosis and prevent the fall in DPN patients. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Diabetic Neuropathy
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Mar 2015to Jun 2016
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diabetics
Who may be able to join
- diabetics
- normal cognitive ability
- walk normally
- normal vision
Who cannot join
- other nervous system disease, foot ulcer
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100000
Geheng Yuan, M.D, +8613811235488, 139197109@qq.com
About this study
Official title: The Balance Control Mechanism of Diabetic Peripheral Neuropathy Patients
This study will evaluate the balance ability of DPN (diabetic peripheral neuropathy)patients, which will help us to understand the relationship between peripheral and central nervous system, in order to early diagnosis and prevent the fall in DPN patients.
Read the detailed description
DPN is one of the most common complications of diabetes. The clinical manifestation of DPN contains sensory reduction, pain, muscle wastage and so on. Sensory and motor nervous are one of the most important factors in balance control, the reduction of balance ability will result in high risk of fall.
Most studies about DPN are focus on peripheral nervous, however, the central nervous system may also be involved in DPN patients. In this study, force platform, proprioception test and fMRI will be used to evaluate balance ability, proprioception and the brain function information of DPN patients, which will help to understand the relationship between peripheral and central nervous system.
- Conditions
- Diabetic Neuropathy
- Keywords
- DPN, fall, fMRI, balance
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
routine blood sugar control
| Study group | Role | What they receive |
|---|---|---|
| Diabetes mellitus with DPN | Aged from 40 to 80. Normal cognitive ability. Right handed. Able to walk without any other kinds of central nervous system disorder. Confirmed diabetes with DPN. | |
| Diabetes mellitus without DPN | Aged from 40 to 80. Normal cognitive ability. Right handed. Able to walk without any other kinds of central nervous system disorder. Confirmed diabetes without DPN. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
In Berg Balance Scale, 14-item scale designed to measure balance of the adult in a clinical setting, including sitting to standing, standing unsupported, sitting unsupported, standing to sitting, transfers, standing with eyes closed, standing with feet together, reaching forward with outstretched arm, retrieving object from floor, turning to look behind, turning 360 degrees, placing alternate foot on stool, standing with one foot in front and standing on one foot. For each item, a five-point scale ranging from 0-4 was recorded. "0" indicates the lowest level of function and "4" the highest level of function. Total Score = 56.
Measured: through study completion, an average of 6 months; Berg Balance Scale assessment
Brain complexity and connectivity
Brain complexity and connectivity was assessed by fMRI (functional magnetic resonance imaging).
For each patient, an 8 minutes resting state fMRI signal was recorded. Brain complexity and connectivity was calculated from fMRI signal. By using AAL (automated anatomical labeling) template, the brain was separated into 90 regions. The complexity of each brain region was calculated and range from 50 to 100. "50" indicates the lowest complexity and "100" indicates the highest complexity. The connectivity between each region was also calculated and range from 0 to 1. "0" indicates the weakest connectivity and "1" indicates the strongest connectivity.
The brain complexity and connectivity in both DPN group and diabetics without DPN group could help us to explore the brain differences between two groups.
Measured: through study completion, an average of 6 months; brain complexity and connectivity assessment
Timed up and go
Timed up and go test was to assess the walk speed of patients. In timed up and go test, the patient sit on a standard armchair and used regular footwear. The patient walk to a line that is 3 meters away, turn around at the line, walk back to the chair, and sit down. The test ends when the patient's buttocks touch the seat. Patients were instructed to use a comfortable and safe walking speed. A stopwatch was used to time the test (in seconds).
Measured: through study completion, an average of 6 months; timed up and go assessment
Foot sole tactile threshold
The foot sole tactile threshold test was to assess the vibration sensation of patients. In foot sole tactile threshold test, the patient was instructed to stand on a pair of vibration insoles. The vibration amplitude was adjusted by experimenter until the patient cannot aware the vibration. The vibration threshold of each foot was recorded from 1 to 100. "1" indicates the weakest vibration and "100" indicates the strongest vibration.
Measured: through study completion, an average of 6 months; foot sole tactile threshold assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Geheng Yuan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Geheng Yuan, Peking University
- Investigators
- Jue Zhang, Ph. D, Study chair, PKU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02606747
- Sponsor's protocol ID
- 11372013
- Status last verified
- Nov 2015
- First submitted
- 9 Apr 2015
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Balance Control Mechanism of Diabetic Peripheral Neuropathy Patients
- ClinicalTrials.gov ID
- NCT02606747
- Acronym / sponsor ID
- 11372013
- Conditions
- Diabetic Neuropathy
- Keywords
- DPN, fall, fMRI, balance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Geheng YuanUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 17 Nov 2015 (estimated)
- 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.
This study will evaluate the balance ability of DPN (diabetic peripheral neuropathy)patients, which will help us to understand the relationship between peripheral and central nervous system, in order to early diagnosis and prevent the fall in DPN patients.
Detailed description
DPN is one of the most common complications of diabetes. The clinical manifestation of DPN contains sensory reduction, pain, muscle wastage and so on. Sensory and motor nervous are one of the most important factors in balance control, the reduction of balance ability will result in high risk of fall.
Most studies about DPN are focus on peripheral nervous, however, the central nervous system may also be involved in DPN patients. In this study, force platform, proprioception test and fMRI will be used to evaluate balance ability, proprioception and the brain function information of DPN patients, which will help to understand the relationship between peripheral and central nervous system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes mellitus with DPN | – | –Aged from 40 to 80. Normal cognitive ability. Right handed. Able to walk without any other kinds of central nervous system disorder. Confirmed diabetes with DPN. |
| Diabetes mellitus without DPN | – | –Aged from 40 to 80. Normal cognitive ability. Right handed. Able to walk without any other kinds of central nervous system disorder. Confirmed diabetes without DPN. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetics
Key inclusion criteria (4 listed)
- diabetics
- normal cognitive ability
- walk normally
- normal vision
Key exclusion criteria (1 listed)
- other nervous system disease, foot ulcer
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 |
|---|---|---|
| routine blood sugar control | Other | Diabetes mellitus with DPN, Diabetes mellitus without DPN |
Primary outcome
Berg Balance Scale
Time frame: through study completion, an average of 6 months; Berg Balance Scale assessment
In Berg Balance Scale, 14-item scale designed to measure balance of the adult in a clinical setting, including sitting to standing, standing unsupported, sitting unsupported, standing to sitting, transfers, standing with eyes closed, standing with feet together, reaching forward with outstretched arm, retrieving object from floor, turning to look behind, turning 360 degrees, placing alternate foot on stool, standing with one foot in front and standing on one foot. For each item, a five-point scale ranging from 0-4 was recorded. "0" indicates the lowest level of function and "4" the highest level of function. Total Score = 56.
Brain complexity and connectivity
Time frame: through study completion, an average of 6 months; brain complexity and connectivity assessment
Brain complexity and connectivity was assessed by fMRI (functional magnetic resonance imaging). For each patient, an 8 minutes resting state fMRI signal was recorded. Brain complexity and connectivity was calculated from fMRI signal. By using AAL (automated anatomical labeling) template, the brain was separated into 90 regions. The complexity of each brain region was calculated and range from 50 to 100. "50" indicates the lowest complexity and "100" indicates the highest complexity. The connectivity between each region was also calculated and range from 0 to 1. "0" indicates the weakest connectivity and "1" indicates the strongest connectivity. The brain complexity and connectivity in both DPN group and diabetics without DPN group could help us to explore the brain differences between two groups.
Timed up and go
Time frame: through study completion, an average of 6 months; timed up and go assessment
Timed up and go test was to assess the walk speed of patients. In timed up and go test, the patient sit on a standard armchair and used regular footwear. The patient walk to a line that is 3 meters away, turn around at the line, walk back to the chair, and sit down. The test ends when the patient's buttocks touch the seat. Patients were instructed to use a comfortable and safe walking speed. A stopwatch was used to time the test (in seconds).
Foot sole tactile threshold
Time frame: through study completion, an average of 6 months; foot sole tactile threshold assessment
The foot sole tactile threshold test was to assess the vibration sensation of patients. In foot sole tactile threshold test, the patient was instructed to stand on a pair of vibration insoles. The vibration amplitude was adjusted by experimenter until the patient cannot aware the vibration. The vibration threshold of each foot was recorded from 1 to 100. "1" indicates the weakest vibration and "100" indicates the strongest vibration.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2015.
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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.
Jue Zhang, Ph. D study chair
PKU
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 Diabetic Neuropathy, run by Geheng Yuan 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 1 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 17 Nov 2015. 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 Ye Wang, Ph. D (+8613718946837, wangyesmile@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (time frame: through study completion, an average of 6 months; Berg Balance Scale assessment). The study lists 4 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 17 Nov 2015.