Magnetic Resonance Diagnostics of Diabetic Peripheral Neuropathy

NCT01847937 | Completed DMC

• 2 other identifiers: 1-10-72-85-13VEK: 1-10-72-85-13
• Study Type: observational
• Target: 115
• Locations: 2 countries
• Sites: 5

Brief Summary

This project aims to develop high field MR techniques to detect nerve lesions in diabetic patients. The MRI findings will be compared to results from conventional evaluations and nerve conduction studies to determine the validity as part of a clinical practice.

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetic Polyneuropathy; Hereditary Axonal Neuropathy; Hereditary Demyelinated Neuropathy; Polyneuropathy, Inflammatory Demyelinating, Chronic

Outcome Measures

Primary Outcomes (1)

• Increase in magnetic resonance signal intensity of segmented nerves

  Magnetic resonance neurography signal intensities from the sciatic, peroneal, and sural nerve is increased in diabetic patients with peripheral neuropathy compared to healthy control subjects.

  within the first 20 days (plus or minus 6 days) after initial MR scan

Secondary Outcomes (3)

• Determine diffusion weighted magnetic resonance values according to neuropathy

  within the first 20 days (plus or minus 6 days) after initial MR scan

• Examination of magnetic resoance morphological differences according to neuropathy

  within the first 20 days (plus or minus 6 days) after initial MR scan

• Correlation of magnetic resoance signal intensity value and nerve conduction thresholds

  within the first 20 days (plus or minus 6 days) after initial MR scan

Study Arms (6)

Diabetics Type I non-neuropathic

Diabetics with type 1 diabetes and without neuropathy

Diabetics Type II non-neuropathic

Diabetics with type 2 diabetes without neuropathy

Diabetics Type I neuropathic

Diabetics with type 1 diabetes and neuropathy

Diabetics Type II neuropathic

Diabetics with type 2 diabetes and neuropathy

Hereditary axonal neuropathic

Hereditary demyelinated neuropathic

This will mainly be patients with Chronic inflammatory demyelinating polyneuropathy (CIDP).

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

In the 3 year course of the study it is expected to include 90 diabetics with and without neuropathy, 10 patients with hereditary axonal neuropathy and 10 patients with demyelinated neuropathy, as well as 35 healthy control subjects. This amounts to a total of 145 subjects.

You may qualify if:

• Clinical diagnosis of type 1 diabetes, without neuropathy
• Clinical diagnosis of type 2 diabetes, without neuropathy
• Clinical diagnosis of type 1 diabetes, with neuropathy
• Clinical diagnosis of type 2 diabetes, with neuropathy
• Clinical diagnosis of hereditary axonal neuropathy
• Clinical diagnosis of hereditary demyelinised neuropathy
• Healthy controls who do not use prescription drugs and are of normal weight (BMI between 20 and 30).

You may not qualify if:

• The second cause of the neuropathy.
• Persons who are under 18.
• Inability to perform nerve conduction study or magnetic resonance imaging.
• Patients with liver disease, hypothyroidism, current or past alcohol abuse, rheumatological diseases and vasculitis.
• Silver Treatment, in diabetics with wounds.

Sponsors & Collaborators

• Aarhus University Hospital: lead
• University of Southern Denmark: collaborator

Study Sites (5)

Department of Endocrinology and Internal Medicine

Aarhus, Aarhus, 8000, Denmark

Location

Department of Neurology

Aarhus, Aarhus, 8000, Denmark

Location

Department of Neurophysiology

Aarhus, Aarhus, 8000, Denmark

Location

MR Centre

Aarhus, Aarhus, 8000, Denmark

Location

Neurologische Universitätsklinik Heidelberg Abteilung für Neuroradiologie

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample less then 250ml to determine Hba1c (blood glucose level).

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetic Neuropathies; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Polyneuropathies; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Vaeggemose, MSc

  Department of Neurology, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: April 12, 2013
• First Posted: May 7, 2013
• Study Start: May 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: February 3, 2017

Record last verified: 2017-02

Locations

DK (4); DE (1)