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

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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Key information

Conditions

Diabetes Mellitus Autonomic Neuropathy Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nervous System Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Peripheral Nervous System Diseases Peripheral Neuropathy Small Fiber Neuropathy Small Fibre Neuropathy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Haukeland University Hospital

Bergen, 5021, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

glucose

Time frame: one year

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Collaborators

Aarhus University Hospital

Registry information

Official study 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

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2013
First posted: Jul 12, 2010
Registry last updated: Jul 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed