Polyneuropathy in Diabetes Mellitus Type 2

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

490 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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T2D patients

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

No interventions assigned to this group

Gender- and age-matched healthy controls

100 healthy subjects

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes