Diabetes Peripheral Neuropathy and Small-fibre Nerve Damage: A Comparative Study

Is Diabetic Peripheral Neuropathy Accompanied by Internal Nerve Damage? A Comparative, Clinical Experimental Study of Peripheral and Visceral Nerve Damage in Diabetic Patients and Healthy Controls

The purpose of this study is to investigate whether patients with diabetes-related peripheral neuropathic pain also have non-recognized damage to the intestine caused by autonomic neuropathy. The model will shed light on aspects of peripheral nerve injuries on both somatic and as well as visceral sensory nerves. Classical autonomic parameters from electrocardiography (ECG) and Holter (24-h ECG and blood pressure) are compared with peripheral nerve injuries. The damage of autonomic nerves often recognized late in the course when patients develop gastroparesis, however an earlier recognition of this nerve damage may help clarifying the fundamental pathomechanisms and thereby optimize treatment for this patient group in the future.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Peripheral Neuropathy; Autonomic Neuropathy; Small Fibre Neuropathy

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway, 5021
    • Haukeland University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with verified diabetic neuropathy.

Description

Inclusion Criteria:

1. Male or female patients between 18 and 75 years with diagnosed diabetes mellitus, according to WHO criteria (World Health Organization).
2. Proven peripheral neuropathy.
3. Oral and written consent, with documentation that all relevant information about the program is given to the patient.
4. The patient must be willing and able to, to meet the planned visit and meet the planned curriculum, including the participation in the experimental investigations.

Exclusion Criteria:

1. Pregnancy or breastfeeding
2. Medical or surgical disease for the study doctor's assessment makes the patient unsuitable for participation in the study
3. Previous or ongoing major depression
4. Patients who can or will not comply with the recommended instructions given by the study doctor
5. Use of analgesic opioid medication less than 24 hours before screening
6. Competitive conditions that can cause peripheral neuropathy (eg, herpes zooster)
7. Clinically significant disease less than 2 weeks from the planned entry in the study
8. People involved in the planning or execution of the study

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patients with diabetic peripheral neuropathy
Healthy matched controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
glucose	one year

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Collaborators: Aarhus University Hospital
• Investigators: Principal Investigator: Georg Dimcevski, MD, PhD, Haukeland University Hospital, Bergen, Norway

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: July 9, 2010
• First Submitted That Met QC Criteria: July 9, 2010
• First Posted (Estimate): July 12, 2010

Study Record Updates

• Last Update Posted (Estimate): July 9, 2013
• Last Update Submitted That Met QC Criteria: July 8, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Small Fiber Neuropathy
• Other Study ID Numbers: 2010/1652