Polyneuropathy in Diabetes Mellitus Type 2

Danish Pain Research Center

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT02947828

IDNC-DD2-NP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 490 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

490 participants in 2 patient groups

T2D patients

Description:

600 type 2 diabetes (T2D) patients recruited from the DD2 cohort

Gender- and age-matched healthy controls

Description:

100 healthy subjects