Dietetic and Hygiene Measures in Metabolic Neuropathies: the Neurodiet Study
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
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:
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the effect of physical training and diet education on neuropathic symptoms and neurophysiological parameters
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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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Coaching active hygienic-dietetic coaching |
Behavioral: hygienic-dietetic measures
Therapeutic education about hygienic-dietetic measures followed by a 5 minutes phone call per week during 3 months
|
Active Comparator: control reference hygienic-dietetic recommendations |
Behavioral: hygienic-dietetic measures
Therapeutic education about hygienic-dietetic measures followed by only one phone call
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Clinical and neurophysiologic neuropathy (clinical signs of neuropathy and at least two low sensory nerve action potential (superficial peroneal and sural nerves))
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Metabolic disorder: Glucose disorder (diabetes mellitus or glucose intolerance) or metabolic syndrome
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Clinical signs for less than 2 years
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No therapeutic modification in the last 3 months
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Possibility to delay any drug modification during 3 months
Exclusion Criteria:
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Non metabolic neuropathy
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Serious diabetic complication
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Renal failure (creatinine clearance<60ml/min)
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Sensory neuronopathy
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Contra-indication to physical activity
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Type 1 diabetes mellitus
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No written consent
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Hôpital Henri Mondor | Créteil | France | 94010 |
Sponsors and Collaborators
- Henri Mondor University Hospital
Investigators
- Principal Investigator: Alain Créange, MD PhD, Henri Mondor University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HM01