Diabetes Peripheral Neuropathy and Small-fibre Nerve Damage: A Comparative Study
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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.
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, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with verified diabetic neuropathy.
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.
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