Clinical trial NCT02947828: Polyneuropathy in Diabetes Mellitus Type 2
Official title: Polyneuropathy in Diabetes Mellitus Type 2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus Type 2 Without Complication
Polyneuropathies, Diabetic
Diabetes Complications
Diabetic Peripheral Neuropathy
Chronic Pain
Keywords: Diabetes Mellitus, Type 2
Polyneuropathies, Diabetic
Lead sponsor: Danish Pain Research Center
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
First posted: 2016-10-28
Enrollment: 490
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Type 2 diabetes patients

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.

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

Primary outcomes:
measure: Presence of diabetic polyneuropathy
timeFrame: 5 hours
measure: Presence of painful diabetic polyneuropathy
timeFrame: 5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Danish Pain Research Center, Aarhus University Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Aarhus University and Aarhus University Hospital
name: Sif Gylfadottir, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Finnerup 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.