NCT02947828

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
490

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 28, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

February 8, 2019

Status Verified

February 1, 2019

Enrollment Period

2.2 years

First QC Date

October 25, 2016

Last Update Submit

February 7, 2019

Conditions

Diabetes Mellitus Type 2 Without ComplicationPolyneuropathies, DiabeticDiabetes ComplicationsDiabetic Peripheral NeuropathyChronic Pain

Keywords

Diabetes Mellitus, Type 2Polyneuropathies, Diabetic

Outcome Measures

Primary Outcomes (2)

  • Presence of diabetic polyneuropathy

    For case definition of neuropathy, Tesfaye et al. 2010 will be used.

    5 hours

  • Presence of painful diabetic polyneuropathy

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

    5 hours

Study Arms (2)

T2D patients

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

Gender- and age-matched healthy controls

100 healthy subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Type 2 diabetes patients

You may qualify if:

  • Clinical diagnosis of type 2 diabetes

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Danish Pain Research Center, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (2)

  • Tesfaye S, Boulton AJ, Dyck PJ, Freeman R, Horowitz M, Kempler P, Lauria G, Malik RA, Spallone V, Vinik A, Bernardi L, Valensi P; Toronto Diabetic Neuropathy Expert Group. Diabetic neuropathies: update on definitions, diagnostic criteria, estimation of severity, and treatments. Diabetes Care. 2010 Oct;33(10):2285-93. doi: 10.2337/dc10-1303.

    PMID: 20876709BACKGROUND

  • Finnerup NB, Haroutounian S, Kamerman P, Baron R, Bennett DLH, Bouhassira D, Cruccu G, Freeman R, Hansson P, Nurmikko T, Raja SN, Rice ASC, Serra J, Smith BH, Treede RD, Jensen TS. Neuropathic pain: an updated grading system for research and clinical practice. Pain. 2016 Aug;157(8):1599-1606. doi: 10.1097/j.pain.0000000000000492.

    PMID: 27115670BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Skin punch biopsies and blood

MeSH Terms

Conditions

Diabetic NeuropathiesDiabetes ComplicationsChronic PainDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes MellitusEndocrine System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Sif Gylfadottir, MD

    Aarhus University and Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2016

First Posted

October 28, 2016

Study Start

October 1, 2016

Primary Completion

November 30, 2018

Study Completion

December 31, 2018

Last Updated

February 8, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will share

Data is shared among collaborators.

Locations

DK(2)