Neuropathic Pain in Elderly People With Diabetes: Impact on Quality of Life and Cognition

April 10, 2019 updated by: Woo Cheuk Wai, Queen Elizabeth Hospital, Hong Kong
This study was set out 1) Evaluate the impact of Diabetic Peripheral Neuropathy (DPN) and DPN-P (Diabetic Peripheral Neuropathic Pain) on the overall Quality of Life (QoL) in elderly with Diabetic Mellitus (DM) and 2) Evaluate the association between cognition impairments and DM in the elderly, and the contributions of DPN and/or DPN-P

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Kowloon, Hong Kong
        • Queen Elizabeth Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with Diabetes Mellitus attending the diabetes clinic and / or pain clinic

Description

Inclusion Criteria:

  • Aged 50 or above
  • Diagnosis of diabetes mellitus (Type 1 or Type 2)

Exclusion Criteria:

  • major psychiatric conditions
  • recent cardiovascular events within the last six months
  • blindness radiculopathy
  • spinal cord injury, multiple sclerosis
  • carpal tunnel syndrome
  • trigeminal neuralgia
  • Subjects who were incompetent in giving written consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
DM
DM without DPN (Diabetic Peripheral Neuropathy)
Behavioral: Cambridge Neuropsychological Test Automated Battery (CANTAB)
Cognition using Cambridge Neuropsychological Test Automated Battery (CANTAB)
Other: Chinese (Hong Kong) 12-item Short-Form Health Survey (version 2)
Quality of Life using Chinese (Hong Kong) 12-item Short-Form Health Survey (version 2)
DPN
DM with DPN (Diabetic Peripheral Neuropathy)
Behavioral: Cambridge Neuropsychological Test Automated Battery (CANTAB)
Cognition using Cambridge Neuropsychological Test Automated Battery (CANTAB)
Other: Chinese (Hong Kong) 12-item Short-Form Health Survey (version 2)
Quality of Life using Chinese (Hong Kong) 12-item Short-Form Health Survey (version 2)
DPN-P
DM with DPN-P (Diabetic Peripheral Neuropathic Pain)
Behavioral: Cambridge Neuropsychological Test Automated Battery (CANTAB)
Cognition using Cambridge Neuropsychological Test Automated Battery (CANTAB)
Other: Chinese (Hong Kong) 12-item Short-Form Health Survey (version 2)
Quality of Life using Chinese (Hong Kong) 12-item Short-Form Health Survey (version 2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognition
Time Frame: Day 1
Identifying cognitive affected domains by using Cambridge Neuropsychological Test Automated Battery (CANTAB) (Reaction Time : RTI, Spatial Working Memory : SWM and Executive Function : OTS)
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life: The Chinese (Hong Kong) 12-item Short-Form Health Survey version 2
Time Frame: Day 1
Identifying Quality of Life affected domains by using The Chinese (Hong Kong) 12-item Short-Form Health Survey version 2
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Elizabeth Hospital, Hong Kong

Investigators

  • Study Chair: Research Ethics Committee (Kowloon Central/ Kowloon East), Research Ethics Committee (Kowloon Central/ Kowloon East)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Actual)

May 31, 2018

Study Completion (Actual)

May 31, 2018

Study Registration Dates

First Submitted

April 8, 2019

First Submitted That Met QC Criteria

April 9, 2019

First Posted (Actual)

April 10, 2019

Study Record Updates

Last Update Posted (Actual)

April 12, 2019

Last Update Submitted That Met QC Criteria

April 10, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KC/KE-17-0070/ER-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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