Diabetes MellitusNCT03909841
Neuropathic Pain in Elderly People With Diabetes: Impact on Quality of Life and Cognition
An observational study of Diabetes Mellitus and Diabetic Peripheral Neuropathy, run by Queen Elizabeth Hospital, Hong Kong at 1 site in Hong Kong.
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… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Diabetic Peripheral Neuropathy, Cognitive Impairment
- What is being tested?
- Cambridge Neuropsychological Test Automated Battery (CANTAB) and Chinese (Hong Kong) 12-item Short-Form Health Survey (version 2)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 48 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2017to 31 May 2018
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with Diabetes Mellitus attending the diabetes clinic and / or pain clinic
Who may be able to join
- Aged 50 or above
- Diagnosis of diabetes mellitus (Type 1 or Type 2)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Cambridge Neuropsychological Test Automated Battery (CANTAB), Chinese (Hong Kong) 12-item Short-Form Health Survey (version 2)
- Medical subject headings
- Diabetes Mellitus, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cambridge Neuropsychological Test Automated Battery (CANTAB)Behavioural
Cognition using Cambridge Neuropsychological Test Automated Battery (CANTAB)
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)
| Study group | Role | What they receive |
|---|---|---|
| DM | DM without DPN (Diabetic Peripheral Neuropathy) Receives: 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) Receives: 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) Receives: Behavioral: Cambridge Neuropsychological Test Automated Battery (CANTAB); Other: Chinese (Hong Kong) 12-item Short-Form Health Survey (version 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognition
Identifying cognitive affected domains by using Cambridge Neuropsychological Test Automated Battery (CANTAB) (Reaction Time : RTI, Spatial Working Memory : SWM and Executive Function : OTS)
Measured: Day 1
Secondary outcomes (1)
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
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start1 Jun 2017
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Elizabeth Hospital, Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Woo Cheuk Wai, Queen Elizabeth Hospital, Hong Kong
- Investigators
- Research Ethics Committee (Kowloon Central/ Kowloon East), Study chair, Research Ethics Committee (Kowloon Central/ Kowloon East)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909841
- Sponsor's protocol ID
- KC/KE-17-0070/ER-1
- Status last verified
- Apr 2019
- First submitted
- 8 Apr 2019
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropathic Pain in Elderly People With Diabetes: Impact on Quality of Life and Cognition
- ClinicalTrials.gov ID
- NCT03909841
- Acronym / sponsor ID
- KC/KE-17-0070/ER-1
- Conditions
- Diabetes Mellitus, Diabetic Peripheral Neuropathy, Cognitive Impairment, Quality of Life, Diabetic Peripheral Neuropathic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Queen Elizabeth Hospital, Hong KongUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 10 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DM | – | Behavioral: Cambridge Neuropsychological Test Automated Battery (CANTAB), Other: Chinese (Hong Kong) 12-item Short-Form Health Survey (version 2)DM without DPN (Diabetic Peripheral Neuropathy) |
| DPN | – | Behavioral: Cambridge Neuropsychological Test Automated Battery (CANTAB), Other: Chinese (Hong Kong) 12-item Short-Form Health Survey (version 2)DM with DPN (Diabetic Peripheral Neuropathy) |
| DPN-P | – | Behavioral: Cambridge Neuropsychological Test Automated Battery (CANTAB), Other: Chinese (Hong Kong) 12-item Short-Form Health Survey (version 2)DM with DPN-P (Diabetic Peripheral Neuropathic Pain) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with Diabetes Mellitus attending the diabetes clinic and / or pain clinic
Key inclusion criteria (2 listed)
- Aged 50 or above
- Diagnosis of diabetes mellitus (Type 1 or Type 2)
Key exclusion criteria (7 listed)
- major psychiatric conditions
- recent cardiovascular events within the last six months
- blindness radiculopathy
- spinal cord injury, multiple sclerosis
- carpal tunnel syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cambridge Neuropsychological Test Automated Battery (CANTAB)Cognition using Cambridge Neuropsychological Test Automated Battery (CANTAB) | Behavioural | DM, DPN, DPN-P |
| 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) | Other | DM, DPN, DPN-P |
Primary outcome
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)
1 secondary outcome
Quality of Life: The Chinese (Hong Kong) 12-item Short-Form Health Survey version 2
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Research Ethics Committee (Kowloon Central/ Kowloon East) study chair
Research Ethics Committee (Kowloon Central/ Kowloon East)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Diabetic Peripheral Neuropathy, run by Queen Elizabeth Hospital, Hong Kong at 1 site in Hong Kong.
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 2 inclusion and 7 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 12 Apr 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 Hong Kong. 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?
Cognition (time frame: Day 1). 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 12 Apr 2019.