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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coaching | Experimental | active hygienic-dietetic coaching |
|
| control | Active Comparator | reference hygienic-dietetic recommendations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hygienic-dietetic measures | Behavioral | Therapeutic education about hygienic-dietetic measures followed by a 5 minutes phone call per week during 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in NTSS6 score at 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) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| clinical global impression of change | 3 months | |
| change from baseline of sensory nerve action potential and sensory and motor nerve velocity | change from baseline of sensory nerve action potential and sensory and motor nerve velocity at 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alain Créange, MD PhD | Henri Mondor University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Henri Mondor | Créteil | 94010 | France |
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| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D003929 | Diabetic Neuropathies |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
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| hygienic-dietetic measures | Behavioral | Therapeutic education about hygienic-dietetic measures followed by only one phone call |
|
| 3 months |
| change from baseline of thermal and vibration thresholds | 3 months |
| D004700 | Endocrine System Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |