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NCT03909841 Clinical Trial

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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03909841
Other study ID # KC/KE-17-0070/ER-1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2017
Est. completion date May 31, 2018

Study information
Verified date April 2019
Source Queen Elizabeth Hospital, Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date May 31, 2018
Est. primary completion date May 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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)

Locations
Country Name City State
Hong Kong Queen Elizabeth Hospital Kowloon

Sponsors (1)
Lead Sponsor Collaborator
Queen Elizabeth Hospital, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

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