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

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ClinicalTrials.gov Identifier: NCT01160887
Recruitment Status : Completed
First Posted : July 12, 2010
Last Update Posted : July 9, 2013
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
Haukeland University Hospital

July 9, 2010
July 12, 2010
July 9, 2013
June 2010
July 2013   (Final data collection date for primary outcome measure)
glucose [ Time Frame: one year ]
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Complete list of historical versions of study NCT01160887 on ClinicalTrials.gov Archive Site
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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.
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Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Probability Sample
Patients with verified diabetic neuropathy.
  • Diabetes Mellitus
  • Peripheral Neuropathy
  • Small Fibre Neuropathy
  • Autonomic Neuropathy
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  • Patients with diabetic peripheral neuropathy
  • Healthy matched controls
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
Same as current
July 2013
July 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
 
NCT01160887
2010/1652
No
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Haukeland University Hospital
Haukeland University Hospital
Aarhus University Hospital
Principal Investigator: Georg Dimcevski, MD, PhD Haukeland University Hospital, Bergen, Norway
Haukeland University Hospital
July 2013