Polyneuropathy in Diabetes Mellitus Type 2

Chronic Pain Clinical Trial

Official title:

Polyneuropathy in Diabetes Mellitus Type 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02947828
• Other study ID #: IDNC-DD2-NP
• Status: Completed
• Start date: October 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2019
• Source: Danish Pain Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 underlying mechanisms, which will hopefully contribute to significant improvements in the treatment and prevention of diabetic polyneuropathy in future.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 490
• Est. completion date: December 31, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Diabetes Complications
• Diabetes Mellitus
• Diabetes Mellitus Type 2 Without Complication
• Diabetes Mellitus, Type 2
• Diabetic Neuropathies
• Diabetic Peripheral Neuropathy
• Peripheral Nervous System Diseases
• Polyneuropathies
• Polyneuropathies, Diabetic

Locations

Country	Name	City	State
Denmark	Danish Pain Research Center, Aarhus University Hospital	Aarhus
Denmark	Odense University Hospital	Odense

Sponsors (2)

Lead Sponsor	Collaborator
Danish Pain Research Center	Odense University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

Finnerup NB, Haroutounian S, Kamerman P, Baron R, Bennett DL, Bouhassira D, Cruccu G, Freeman R, Hansson P, Nurmikko T, Raja SN, Rice AS, Serra J, Smith BH, Treede RD, Jensen TS. Neuropathic pain: an updated grading system for research and clinical practice. Pain. 2016 Aug;157(8):1599-606. doi: 10.1097/j.pain.0000000000000492. Review. — View Citation

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. Review. Erratum in: Diabetes Care. 2010 Dec;33(12):2725. — View Citation

Outcome

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