Hôpital Henri Mondor
Créteil, 94010, France
NCT Number: NCT01465620
Metabolic disorders such as diabetes mellitus, glucose intolerance and possibly metabolic syndrome can induce a peripheral neuropathy. To investigate the effect of physical training and diet education on neuropathic symptoms and neurophysiological parameters of patients with metabolic neuropathies.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Créteil, 94010, France
Metabolic disorder such as diabetes mellitus, glucose intolerance and possibly metabolic syndrome can induce a peripheral neuropathy. The objectives of the present study are to investigate:
This will be a prospective single blind study (blinded evaluator). Patients will be randomly assigned in two groups. The first group will have a one-day therapeutic education program followed by a 5-minutes phone call every week for 3 months. The second group will have the same one-day therapeutic education program that will be followed by an unique one-hour phone call. During the one-day therapeutic education program and the phone calls, hygienic rules (ie physical activities) and dietetic regimen advices will be given to patients. Evaluation will be done at 3 months.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Therapeutic education about hygienic-dietetic measures followed by a 5 minutes phone call per week during 3 months
Time frame: 3 months
Change from Baseline in NTSS6 score at 3 months (Bastyr EJ, 3rd, Price KL, Bril V. Development and validity testing of the neuropathy total symptom score-6: questionnaire for the study of sensory symptoms of diabetic peripheral neuropathy. Clin Ther. 2005 Aug;27(8):1278-94)
Time frame: 3 months
Time frame: 3 months
change from baseline of sensory nerve action potential and sensory and motor nerve velocity at 3 months
Time frame: 3 months
Henri Mondor University Hospital
Other
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