Diabetes Mellitus Type 2 Without ComplicationNCT02947828
Polyneuropathy in Diabetes Mellitus Type 2
An observational study of Diabetes Mellitus Type 2 Without Complication and Polyneuropathies, Diabetic, run by Danish Pain Research Center at 2 sites in Denmark.
Trial summary
This is a population-based study of type 2 diabetes patients with and without neuropathy recruited from the Danish National Type 2 Diabetes cohort (DD2). Perspective: The study will identify risk factors for developing diabetic polyneuropathy and painful diabetic polyneuropathy and provide information on the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus Type 2 Without Complication, Polyneuropathies, Diabetic, Diabetes Complications
- How many people
- 490 participants
- Where
- 2 sitesDenmark
- Study dates
- Oct 2016to 31 Dec 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Type 2 diabetes patients
Who may be able to join
- Clinical diagnosis of type 2 diabetes
Who cannot join
- Pregnancy
- Poor or no Danish language skills
- Insufficient mental capacity to provide informed consent or complete questionnaires
- Additional criteria for healthy controls:
- Any neurological or psychiatric disorder
- Chronic pain
- Severe illness
- Pain treatment 3 days before the examination
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Danish Pain Research Center, Aarhus University Hospital
Aarhus, 8000
Odense University Hospital
Odense, 5000
About this study
This is a population-based study of type 2 diabetes patients with and without neuropathy recruited from the Danish National Type 2 Diabetes cohort (DD2).
Perspective: The study will identify risk factors for developing diabetic polyneuropathy and painful diabetic polyneuropathy and provide information on the underlying mechanisms, which will hopefully contribute to significant improvements in the treatment and prevention of diabetic polyneuropathy in future.
Read the detailed description
Diabetic polyneuropathy is one of the most common long-term complications of diabetes. Neuronal hyperexcitability is thought to be a key factor in the development of neuropathic pain.
The overall purpose of this study is to evaluate the prevalence and underlying mechanisms of diabetic polyneuropathy and painful diabetic polyneuropathy.
- Conditions
- Diabetes Mellitus Type 2 Without Complication, Polyneuropathies, Diabetic, Diabetes Complications, Diabetic Peripheral Neuropathy, Chronic Pain
- Keywords
- Diabetes Mellitus, Type 2, Polyneuropathies, Diabetic
- Medical subject headings
- Diabetic Neuropathies, Diabetes Complications, Chronic Pain, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| T2D patients | 600 type 2 diabetes (T2D) patients recruited from the DD2 cohort | |
| Gender- and age-matched healthy controls | 100 healthy subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of diabetic polyneuropathy
For case definition of neuropathy, Tesfaye et al. 2010 will be used.
Measured: 5 hours
Presence of painful diabetic polyneuropathy
Neuropathic pain grading system. Finnerup et al. 2016 will be used.
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study startOct 2016
- Primary completion30 Nov 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 2 Without ComplicationStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 490 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Pain Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital
- Responsible party
- Sponsor
- Investigators
- Sif Gylfadottir, MD, Principal investigator, Aarhus University and Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02947828
- Sponsor's protocol ID
- IDNC-DD2-NP
- Status last verified
- Feb 2019
- First submitted
- 25 Oct 2016
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data is shared among collaborators.
Publications
Tesfaye S, Boulton AJ, Dyck PJ, Freeman R, Horowitz M, Kempler P, Lauria G, Malik RA, Spallone V, Vinik A, Bernardi L, Valensi P; Toronto Diabetic Neuropathy Expert Group. Diabetic neuropathies: update on definitions, diagnostic criteria, estimation of severity, and treatments. Diabetes Care. 2010 Oct;33(10):2285-93. doi: 10.2337/dc10-1303.
PubMed 20876709Finnerup NB, Haroutounian S, Kamerman P, Baron R, Bennett DLH, Bouhassira D, Cruccu G, Freeman R, Hansson P, Nurmikko T, Raja SN, Rice ASC, Serra J, Smith BH, Treede RD, Jensen TS. Neuropathic pain: an updated grading system for research and clinical practice. Pain. 2016 Aug;157(8):1599-1606. doi: 10.1097/j.pain.0000000000000492.
PubMed 27115670
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polyneuropathy in Diabetes Mellitus Type 2
- ClinicalTrials.gov ID
- NCT02947828
- Acronym / sponsor ID
- IDNC-DD2-NP
- Conditions
- Diabetes Mellitus Type 2 Without Complication, Polyneuropathies, Diabetic, Diabetes Complications, Diabetic Peripheral Neuropathy, Chronic Pain
- Keywords
- Diabetes Mellitus, Type 2, Polyneuropathies, Diabetic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 490 participants (actual)
- Lead sponsor
- Danish Pain Research CenterUniversity, hospital or other
- Collaborators
- Odense University Hospital
- Study start
- Oct 2016 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 28 Oct 2016 (estimated)
- 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 is a population-based study of type 2 diabetes patients with and without neuropathy recruited from the Danish National Type 2 Diabetes cohort (DD2).
Perspective: The study will identify risk factors for developing diabetic polyneuropathy and painful diabetic polyneuropathy and provide information on the underlying mechanisms, which will hopefully contribute to significant improvements in the treatment and prevention of diabetic polyneuropathy in future.
Detailed description
Diabetic polyneuropathy is one of the most common long-term complications of diabetes. Neuronal hyperexcitability is thought to be a key factor in the development of neuropathic pain.
The overall purpose of this study is to evaluate the prevalence and underlying mechanisms of diabetic polyneuropathy and painful diabetic polyneuropathy.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T2D patients | – | –600 type 2 diabetes (T2D) patients recruited from the DD2 cohort |
| Gender- and age-matched healthy controls | – | –100 healthy subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Type 2 diabetes patients
Key inclusion criteria (1 listed)
- Clinical diagnosis of type 2 diabetes
Key exclusion criteria (8 listed)
- Pregnancy
- Poor or no Danish language skills
- Insufficient mental capacity to provide informed consent or complete questionnaires
- Any neurological or psychiatric disorder
- Chronic pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of diabetic polyneuropathy
Time frame: 5 hours
For case definition of neuropathy, Tesfaye et al. 2010 will be used.
Presence of painful diabetic polyneuropathy
Time frame: 5 hours
Neuropathic pain grading system. Finnerup et al. 2016 will be used.
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 8 Feb 2019.
- Background: PubMed 20876709Tesfaye S, Boulton AJ, Dyck PJ, Freeman R, Horowitz M, Kempler P, Lauria G, Malik RA, Spallone V, Vinik A, Bernardi L, Valensi P; Toronto Diabetic Neuropathy Expert Group. Diabetic neuropathies: update on definitions, diagnostic criteria, estimation of severity, and treatments. Diabetes Care. 2010 Oct;33(10):2285-93. doi: 10.2337/dc10-1303.
- Background: PubMed 27115670Finnerup NB, Haroutounian S, Kamerman P, Baron R, Bennett DLH, Bouhassira D, Cruccu G, Freeman R, Hansson P, Nurmikko T, Raja SN, Rice ASC, Serra J, Smith BH, Treede RD, Jensen TS. Neuropathic pain: an updated grading system for research and clinical practice. Pain. 2016 Aug;157(8):1599-1606. doi: 10.1097/j.pain.0000000000000492.
- Individual participant dataSharing planned: Yes. Data is shared among collaborators.
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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.
Sif Gylfadottir, MD principal investigator
Aarhus University and Aarhus University Hospital
2 sites 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 Type 2 Without Complication and Polyneuropathies, Diabetic, run by Danish Pain Research Center at 2 sites in Denmark.
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 1 inclusion and 8 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 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
Presence of diabetic polyneuropathy (time frame: 5 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02947828, which also lists 2 linked publications.
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 8 Feb 2019; AzTrials last refreshed its copy on 1 Nov 2026.