Polyneuropathy in Diabetes Mellitus Type 2

Completed

• Conditions: Diabetes Mellitus Type 2 Without Complication; Diabetic Peripheral Neuropathy; Polyneuropathies, Diabetic; Chronic Pain; Diabetes Complications

• Registration Number: NCT02947828
• Lead Sponsor: Danish Pain Research Center

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.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-25
• Study First Submitted QC: 2016-10-26
• Study First Posted: 2016-10-28
• Primary Completion: 2018-11-30
• Study Completion: 2018-12-31
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-07
• Last Update Posted: 2019-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 490

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Odense University Hospital; 🇩🇰 Odense, Denmark

Danish Pain Research Center, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark