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

• Sponsor: Haukeland University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01160887
• Collaborator: Aarhus University Hospital (Other)
• Enrollment: 40
• Location: 1
• Duration (Months): 37
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus; Peripheral Neuropathy; Small Fibre Neuropathy; Autonomic Neuropathy

Study Design

• Study Type: Observational
• Actual Enrollment: 40 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• 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
• Study Start Date: Jun 1, 2010
• Actual Primary Completion Date: Jul 1, 2013
• Actual Study Completion Date: Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Patients with diabetic peripheral neuropathy
Healthy matched controls

Outcome Measures

Primary Outcome Measures

1. glucose [one year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Haukeland University Hospital	Bergen		Norway	5021

Sponsors and Collaborators

• Haukeland University Hospital
• Aarhus University Hospital

Investigators

• Principal Investigator: Georg Dimcevski, MD, PhD, Haukeland University Hospital, Bergen, Norway

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Haukeland University Hospital
• ClinicalTrials.gov Identifier: NCT01160887
• Other Study ID Numbers: 2010/1652
• First Posted: Jul 12, 2010
• Last Update Posted: Jul 9, 2013
• Last Verified: Jul 1, 2013

• Additional relevant MeSH terms: Peripheral Nervous System Diseases; Small Fiber Neuropathy

Study Results

No Results Posted as of Jul 9, 2013