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

This study has been completed.
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01160887
First received: July 9, 2010
Last updated: July 8, 2013
Last verified: July 2013
  Purpose

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
Diabetes Mellitus
Peripheral Neuropathy
Small Fibre Neuropathy
Autonomic Neuropathy

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • glucose [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: June 2010
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with diabetic peripheral neuropathy
Healthy matched controls

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients with verified diabetic neuropathy.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01160887

Locations
Norway
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
  More Information

No publications provided

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01160887     History of Changes
Other Study ID Numbers: 2010/1652
Study First Received: July 9, 2010
Last Updated: July 8, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Additional relevant MeSH terms:
Diabetes Mellitus
Peripheral Nervous System Diseases
Nervous System Diseases
Erythromelalgia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Neuromuscular Diseases
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 16, 2014