Dietetic and Hygiene Measures in Metabolic Neuropathies: the Neurodiet Study

Henri Mondor University Hospital8 enrolled

Overview

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: 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Peripheral Nervous System Diseases Diabetic Polyneuropathy Metabolic Syndrome X

Interventions

hygienic-dietetic measuresBEHAVIORAL

Therapeutic education about hygienic-dietetic measures followed by a 5 minutes phone call per week during 3 months

hygienic-dietetic measuresBEHAVIORAL

Therapeutic education about hygienic-dietetic measures followed by only one phone call

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hôpital Henri Mondor

Créteil, France

Outcomes

Primary Outcomes

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)

Time frame: 3 months

Secondary Outcomes

clinical global impression of change

Time frame: 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

Time frame: 3 months

change from baseline of thermal and vibration thresholds

Time frame: 3 months

Data from ClinicalTrials.gov

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