Polyneuropathy in Diabetes Mellitus Type 2 | NCT02947828

Studies
Polyneuropathy in Diabetes Mellitus Type 2

NCT02947828

Sponsor

Danish Pain Research Center

Status

Completed

Last Update Posted

Feb 8, 2019Actual

Enrollment

490Actual

Phase

Not provided

Conditions

Diabetes Mellitus Type 2 Without Complication
Polyneuropathies, Diabetic
Diabetes Complications
Diabetic Peripheral Neuropathy
Chronic Pain

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016Actual

Primary Completion Date

Nov 30, 2018Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

Oct 25, 2016

First Submission Date that Met QC Criteria

Oct 26, 2016

First Posted Date

Oct 28, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 7, 2019

Last Update Posted Date

Feb 8, 2019Actual

Name	Class
Odense University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

490Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
T2D patients		600 type 2 diabetes (T2D) patients recruited from the DD2 cohort
Gender- and age-matched healthy controls		100 healthy subjects

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Presence of diabetic polyneuropathy	For case definition of neuropathy, Tesfaye et al. 2010 will be used.	5 hours
Presence of painful diabetic polyneuropathy	Neuropathic pain grading system. Finnerup et al. 2016 will be used.	5 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria T2D patients:

Clinical diagnosis of type 2 diabetes

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Type 2 diabetes patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sif Gylfadottir, MD	Aarhus University and Aarhus University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Danish Pain Research Center, Aarhus University Hospital		Aarhus		8000	Denmark
Odense University Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20876709	Background	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.
27115670

ID	Term
D003929	Diabetic Neuropathies
D048909	Diabetes Complications
D059350	Chronic Pain
D003924	Diabetes Mellitus, Type 2

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D003920	Diabetes Mellitus