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

NCT01160887 | Completed

• 1 other identifier: 2010/1652
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Peripheral Neuropathy; Small Fibre Neuropathy; Autonomic Neuropathy

Outcome Measures

Primary Outcomes (1)

• glucose

  one year

Study Arms (2)

Patients with diabetic peripheral neuropathy

Healthy matched controls

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with verified diabetic neuropathy.

You may qualify if:

• Male or female patients between 18 and 75 years with diagnosed diabetes mellitus, according to WHO criteria (World Health Organization).
• Proven peripheral neuropathy.
• Oral and written consent, with documentation that all relevant information about the program is given to the patient.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Haukeland University Hospital: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Haukeland University Hospital

Bergen, 5021, Norway

Location

MeSH Terms

Conditions

Diabetes Mellitus; Peripheral Nervous System Diseases; Small Fiber Neuropathy

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Georg Dimcevski, MD, PhD

  Haukeland University Hospital, Bergen, Norway

  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: July 9, 2010
• First Posted: July 12, 2010
• Study Start: June 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 9, 2013

Record last verified: 2013-07

Locations

NO (1)