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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01160887
• Other study ID #: 2010/1652
• Status: Completed
• Phase: N/A
• First received: July 9, 2010
• Last updated: July 8, 2013
• Start date: June 2010
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Autonomic Neuropathy
• Diabetes Mellitus
• Erythromelalgia
• Nervous System Diseases
• Peripheral Nervous System Diseases
• Peripheral Neuropathy
• Small Fibre Neuropathy

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen

Sponsors (2)

Lead Sponsor	Collaborator
Haukeland University Hospital	Aarhus University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glucose		one year	No