Diabetic Polyneuropathy, Metabolic Syndrome X, Peripheral Nervous System Diseases
Conditions
Keywords
Peripheral Nervous System Diseases, Diabetic Polyneuropathy, Metabolic Syndrome X
Brief summary
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.
Detailed description
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: 1. the effect of physical training and diet education on neuropathic symptoms and neurophysiological parameters 2. the best coaching modality of education. 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.
Interventions
BEHAVIORALhygienic-dietetic measures
Therapeutic education about hygienic-dietetic measures followed by a 5 minutes phone call per week during 3 months
Sponsors
Henri Mondor University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical and neurophysiologic neuropathy (clinical signs of neuropathy and at least two low sensory nerve action potential (superficial peroneal and sural nerves)) * Metabolic disorder: Glucose disorder (diabetes mellitus or glucose intolerance) or metabolic syndrome * Clinical signs for less than 2 years * No therapeutic modification in the last 3 months * Possibility to delay any drug modification during 3 months
Exclusion criteria
* Non metabolic neuropathy * Serious diabetic complication * Renal failure (creatinine clearance\<60ml/min) * Sensory neuronopathy * Contra-indication to physical activity * Type 1 diabetes mellitus * No written consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in NTSS6 score at 3 months | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clinical global impression of change | 3 months | — |
| change from baseline of sensory nerve action potential and sensory and motor nerve velocity | 3 months | change from baseline of sensory nerve action potential and sensory and motor nerve velocity at 3 months |
| change from baseline of thermal and vibration thresholds | 3 months | — |
Countries
France
Outcome results
None listed