Dietetic and Hygiene Measures in Metabolic Neuropathies: the Neurodiet Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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: the effect of physical training and diet education on neuropathic symptoms and neurophysiological parameters 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.

Official Title
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Dietetic and Hygiene Measures in Metabolic Neuropathies: the Neurodiet Study

Conditions
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Peripheral Nervous System Diseases, Diabetic Polyneuropathy, Metabolic Syndrome X

Intervention / Treatment
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* Behavioral: hygienic-dietetic measures
* Behavioral: hygienic-dietetic measures


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coaching<br>active hygienic-dietetic coaching | Behavioral: hygienic-dietetic measures<br>* Therapeutic education about hygienic-dietetic measures followed by a 5 minutes phone call per week during 3 months<br>|
| Active Comparator: control<br>reference hygienic-dietetic recommendations | Behavioral: hygienic-dietetic measures<br>* Therapeutic education about hygienic-dietetic measures followed by only one phone call<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 3 months | 
| change from baseline of thermal and vibration thresholds |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral Nervous System Diseases, Diabetic Polyneuropathy, Metabolic Syndrome X