Polyneuropathy in Diabetes Mellitus Type 2

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.

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Key information

Conditions

Diabetes Mellitus Type 2 Without Complication Chronic Pain Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetic Neuropathies Diabetic Peripheral Neuropathy Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Nutritional and Metabolic Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Polyneuropathies, Diabetic Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Danish Pain Research Center, Aarhus University Hospital, Aarhus, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Presence of diabetic polyneuropathy

Time frame: 5 hours

For case definition of neuropathy, Tesfaye et al. 2010 will be used.
Presence of painful diabetic polyneuropathy

Time frame: 5 hours

Neuropathic pain grading system. Finnerup et al. 2016 will be used.

Sponsors and collaborators

Lead sponsor

Danish Pain Research Center

Other

Collaborators

Odense University Hospital

Registry information

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Oct 28, 2016
Registry last updated: Feb 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed