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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Japan1 site
  • Okayama University

    Okayama, 7008558

Other trials in Japan

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 groups in NCT03440203
Study groupRoleWhat they receive
no Diabetic neuropathyNot described
Receives: Other: difficult activities of daily living in each group
Diabetic peripheral neuropathyNot described
Receives: Other: difficult activities of daily living in each group
Diabetic peripheral neuropathic painNot 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.

  1. 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.

  1. First posted22 Feb 2018
  2. Study start11 May 2017
  3. Primary completion22 Oct 2017
  4. Study completion22 Oct 2017

Resources

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
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

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.

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