Diabetic Neuropathy PeripheralNCT03440203
Prevalence of Peripheral Neuropathy and Its Impact on Activities of Daily Living in Patients With Type 2 Diabetes
An observational study of Diabetic Neuropathy Peripheral and Activities of Daily Living, run by Okayama University at 1 site in Japan.
Trial summary
The trend of diabetes prevalence was increased by comparing these two national surveys in 2009 and 2014. However, the studies only focused on the prevalence and risk of diabetes and non-communicable diseases in Myanmar. The study focused on the common complications of Diabetic Peripheral Neuropathy (DPN) is rare. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Diabetic Neuropathy Peripheral, Activities of Daily Living
- What is being tested?
- difficult activities of daily living in each group
- How many people
- 975 participants
- Where
- 1 siteJapan
- Study dates
- 11 May 2017to 22 Oct 2017
- How long will I take part?
- 1 Day
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients went to the diabetic clinic at the outpatient department of Yangon General Hospital (YGH), North-Okkalapa General Hospital (NOGH), East Yangon General Hospital (EYGH), and West Yangon General Hospital (WYGH) in Myanmar used as the sample. These four hospitals are providing outpatient services for diabetics on selected weekdays. Most of the patients who are receiving the care are from Yangon Region.
Who may be able to join
- people aged over 25 years of age who have already been diagnosed with type 2 diabetes mellitus, and who are taking anti-glycemic treatment
Who cannot join
- people who are suffering from neuropathy and neuropathic pain other than diabetes, severe illness of diabetic patients, mental illness and alcoholism
Trial locations and contacts
1 site in 1 country.
About this study
The trend of diabetes prevalence was increased by comparing these two national surveys in 2009 and 2014. However, the studies only focused on the prevalence and risk of diabetes and non-communicable diseases in Myanmar. The study focused on the common complications of Diabetic Peripheral Neuropathy (DPN) is rare. The studies in other countries showed high prevalence rate and under-diagnosis of DPN. Most of the patients with DPN did not complain about their symptoms because of without prominent symptoms. DPN is the major complication of diabetes. According to the international studies, DPN has the hidden epidemic and is the common causes which can lead to disability and decreased the quality of life in diabetes. Therefore, the study focused on the prevalence of DPN and its impact on the ADLs is obligatory as the descriptive study to explore the actual situation.
Nursing care is not only for the patients in the hospital but also for the people in the community. Moreover, the nurses have to focus on all levels of prevention. Diabetes is the lifelong diseases and accessibility of health care for everyone with diabetes is a very important issue in the era with increased prevalence of diabetes. Therefore, we all have to focus not only on the primary prevention but also on the secondary and tertiary prevention of diabetes. The secondary and tertiary prevention in the diabetic patients also means the primary prevention of other diseases and disabilities (the complications of diabetes). For diabetic neuropathic patients, maintaining normal daily living is very important liked everyone.
Read more
The objective of this study is to evaluate the prevalence of DPN and DPNP in type 2 diabetic patients and impact on the activities of daily living. The descriptive, cross-sectional study design will be used in this study. The inclusion criteria are the person aged over 25 years of age who had already diagnosed type 2 diabetes mellitus, taking any anti-glycemic treatment. The persons who are suffering from neuropathy and neuropathic pain other than diabetes, severe illness of diabetic patients, mental illness and alcoholism will be excluded from this study. The patients who meet the inclusion criteria and come to outpatient diabetic clinics at YGH, NOGH, EYGH, and WYGH will be chosen as a sample after obtaining informed consent.
Data collection will be done at this outpatients diabetic clinic of these four hospitals. This study has already obtained ethical clearance from Nursing Science Ethical Review Committee, Graduate School of Health Sciences, Okayama University, Japan with the review number D1605. It will be carrying out after obtaining approval from Department of Medical Research, Myanmar. At the outset, informed consent will be obtained with detailed information about the purpose of research, the part they need to participate, possible benefits and their rights to withdraw.
- Being tested
- difficult activities of daily living in each group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
difficult activities of daily living in each groupOther
Also called severity of pain in each group
Compare the severity of pain by the severity of diabetic peripheral neuropathy. Compare the difficulties in ADLs in three group of diabetic patients
| Study group | Role | What they receive |
|---|---|---|
| no Diabetic neuropathy | Not described Receives: Other: difficult activities of daily living in each group | |
| Diabetic peripheral neuropathy | Not described Receives: Other: difficult activities of daily living in each group | |
| Diabetic peripheral neuropathic pain | Not described Receives: Other: difficult activities of daily living in each group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activities of daily living
Measured: on the days of data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start11 May 2017
- Primary completion22 Oct 2017
- Study completion22 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Neuropathy PeripheralStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 975 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Okayama University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mi Mi Thet Mon Win, Okayama University
- Investigators
- Mi Mi Thet Mon Win, PhD student, Principal investigator, Graduate School of Health Sciences, Okayama University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03440203
- Sponsor's protocol ID
- D16-05
- Other IDs
- Ethics/DMR/2017/049
- Status last verified
- May 2019
- First submitted
- 14 Feb 2018
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Peripheral Neuropathy and Its Impact on Activities of Daily Living in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03440203
- Acronym / sponsor ID
- D16-05
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 975 participants (actual)
- Lead sponsor
- Okayama UniversityUniversity, hospital or other
- Study start
- 11 May 2017 (actual)
- Primary completion
- 22 Oct 2017 (actual)
- Study completion
- 22 Oct 2017 (actual)
- First posted
- 22 Feb 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.
The trend of diabetes prevalence was increased by comparing these two national surveys in 2009 and 2014. However, the studies only focused on the prevalence and risk of diabetes and non-communicable diseases in Myanmar. The study focused on the common complications of Diabetic Peripheral Neuropathy (DPN) is rare. The studies in other countries showed high prevalence rate and under-diagnosis of DPN. Most of the patients with DPN did not complain about their symptoms because of without prominent symptoms. DPN is the major complication of diabetes. According to the international studies, DPN has the hidden epidemic and is the common causes which can lead to disability and decreased the quality of life in diabetes. Therefore, the study focused on the prevalence of DPN and its impact on the ADLs is obligatory as the descriptive study to explore the actual situation.
Nursing care is not only for the patients in the hospital but also for the people in the community. Moreover, the nurses have to focus on all levels of prevention. Diabetes is the lifelong diseases and accessibility of health care for everyone with diabetes is a very important issue in the era with increased prevalence of diabetes. Therefore, we all have to focus not only on the primary prevention but also on the secondary and tertiary prevention of diabetes. The secondary and tertiary prevention in the diabetic patients also means the primary prevention of other diseases and disabilities (the complications of diabetes). For diabetic neuropathic patients, maintaining normal daily living is very important liked everyone.
The objective of this study is to evaluate the prevalence of DPN and DPNP in type 2 diabetic patients and impact on the activities of daily living. The descriptive, cross-sectional study design will be used in this study. The inclusion criteria are the person aged over 25 years of age who had already diagnosed type 2 diabetes mellitus, taking any anti-glycemic treatment. The persons who are suffering from neuropathy and neuropathic pain other than diabetes, severe illness of diabetic patients, mental illness and alcoholism will be excluded from this study. The patients who meet the inclusion criteria and come to outpatient diabetic clinics at YGH, NOGH, EYGH, and WYGH will be chosen as a sample after obtaining informed consent.
Data collection will be done at this outpatients diabetic clinic of these four hospitals. This study has already obtained ethical clearance from Nursing Science Ethical Review Committee, Graduate School of Health Sciences, Okayama University, Japan with the review number D1605. It will be carrying out after obtaining approval from Department of Medical Research, Myanmar. At the outset, informed consent will be obtained with detailed information about the purpose of research, the part they need to participate, possible benefits and their rights to withdraw.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| no Diabetic neuropathy | – | Other: difficult activities of daily living in each group |
| Diabetic peripheral neuropathy | – | Other: difficult activities of daily living in each group |
| Diabetic peripheral neuropathic pain | – | Other: difficult activities of daily living in each group |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients went to the diabetic clinic at the outpatient department of Yangon General Hospital (YGH), North-Okkalapa General Hospital (NOGH), East Yangon General Hospital (EYGH), and West Yangon General Hospital (WYGH) in Myanmar used as the sample. These four hospitals are providing outpatient services for diabetics on selected weekdays. Most of the patients who are receiving the care are from Yangon Region.
Key inclusion criteria (1 listed)
- people aged over 25 years of age who have already been diagnosed with type 2 diabetes mellitus, and who are taking anti-glycemic treatment
Key exclusion criteria (1 listed)
- people who are suffering from neuropathy and neuropathic pain other than diabetes, severe illness of diabetic patients, mental illness and alcoholism
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 |
|---|---|---|
| difficult activities of daily living in each groupAlso: severity of pain in each groupCompare the severity of pain by the severity of diabetic peripheral neuropathy. Compare the difficulties in ADLs in three group of diabetic patients | Other | Diabetic peripheral neuropathic pain, Diabetic peripheral neuropathy, no Diabetic neuropathy |
Primary outcome
Activities of daily living
Time frame: on the days of data collection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
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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.
Mi Mi Thet Mon Win, PhD student principal investigator
Graduate School of Health Sciences, Okayama University
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 Peripheral and Activities of Daily Living, run by Okayama University at 1 site in Japan.
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 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: finished, as of the sponsor's last update on 10 May 2019. 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 Japan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activities of daily living (time frame: on the days of data collection). 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 10 May 2019; AzTrials last refreshed its copy on 7 Nov 2026.