Polyneuropathy in Diabetes Mellitus Type 2

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02947828

Enrollment

490

Registered

2016-10-28

Start date

2016-10-31

Completion date

2018-12-31

Last updated

2019-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Diabetes Mellitus, Type 2, Polyneuropathies, Diabetic

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

Denmark

Outcome results