Prevalence of Peripheral Neuropathy and Its Impact on Activities of Daily Living in Patients With Type 2 Diabetes

Sponsor
Okayama University (Other)
Overall Status
Completed
CT.gov ID
NCT03440203
Collaborator
(none)
975
1
5.4
181

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Other: difficult activities of daily living in each group

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
975 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Prevalence of Peripheral Neuropathy and Its Impact on Activities of Daily Living in Patients With Type 2 Diabetes
Actual Study Start Date :
May 11, 2017
Actual Primary Completion Date :
Oct 22, 2017
Actual Study Completion Date :
Oct 22, 2017

Arms and Interventions

Arm Intervention/Treatment
no Diabetic neuropathy

Other: difficult activities of daily living 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
Other Names:
  • severity of pain in each group
  • Diabetic peripheral neuropathy

    Other: difficult activities of daily living 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
    Other Names:
  • severity of pain in each group
  • Diabetic peripheral neuropathic pain

    Other: difficult activities of daily living 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
    Other Names:
  • severity of pain in each group
  • Outcome Measures

    Primary Outcome Measures

    1. Activities of daily living [on the days of data collection]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • people aged over 25 years of age who have already been diagnosed with type 2 diabetes mellitus, and who are taking anti-glycemic treatment
    Exclusion Criteria:
    • people who are suffering from neuropathy and neuropathic pain other than diabetes, severe illness of diabetic patients, mental illness and alcoholism

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Okayama University Okayama Japan 7008558

    Sponsors and Collaborators

    • Okayama University

    Investigators

    • Principal Investigator: Mi Mi Thet Mon Win, PhD student, Graduate School of Health Sciences, Okayama University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mi Mi Thet Mon Win, Graduate Student, Okayama University
    ClinicalTrials.gov Identifier:
    NCT03440203
    Other Study ID Numbers:
    • D16-05
    • Ethics/DMR/2017/049
    First Posted:
    Feb 22, 2018
    Last Update Posted:
    May 10, 2019
    Last Verified:
    May 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 10, 2019