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

NCT03909841 | Completed DMC

• 1 other identifier: KC/KE-17-0070/ER-1
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Diabetes Mellitus; Diabetic Peripheral Neuropathy; Cognitive Impairment; Quality of Life; Diabetic Peripheral Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Quality of Life: The Chinese (Hong Kong) 12-item Short-Form Health Survey version 2

  Day 1

Study Arms (3)

DM

DM without DPN (Diabetic Peripheral Neuropathy)

Behavioral: Cambridge Neuropsychological Test Automated Battery (CANTAB); Other: 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); Other: 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); Other: Chinese (Hong Kong) 12-item Short-Form Health Survey (version 2)

Interventions

Cambridge Neuropsychological Test Automated Battery (CANTAB) BEHAVIORAL

Cognition using Cambridge Neuropsychological Test Automated Battery (CANTAB)

DM; DPN; DPN-P

Chinese (Hong Kong) 12-item Short-Form Health Survey (version 2) OTHER

Quality of Life using Chinese (Hong Kong) 12-item Short-Form Health Survey (version 2)

DM; DPN; DPN-P

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen Elizabeth Hospital, Hong Kong: lead

Study Sites (1)

Queen Elizabeth Hospital

Kowloon, Hong Kong

Location

MeSH Terms

Conditions

Diabetes Mellitus; Cognitive Dysfunction

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Research Ethics Committee (Kowloon Central/ Kowloon East)

  Research Ethics Committee (Kowloon Central/ Kowloon East)

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 10, 2019
• Study Start: June 1, 2017
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: April 12, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)