Clinical trial NCT01465620: Dietetic and Hygiene Measures in Metabolic Neuropathies: the Neurodiet Study
Official title: Dietetic and Hygiene Measures in Metabolic Neuropathies: the Neurodiet Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peripheral Nervous System Diseases
Diabetic Polyneuropathy
Metabolic Syndrome X
Keywords: Peripheral Nervous System Diseases
Diabetic Polyneuropathy
Metabolic Syndrome X
Lead sponsor: Henri Mondor University Hospital
Sponsor class: OTHER
First posted: 2011-11-06
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in NTSS6 score at 3 months
timeFrame: 3 months
Secondary outcomes:
measure: clinical global impression of change
timeFrame: 3 months
measure: change from baseline of sensory nerve action potential and sensory and motor nerve velocity
timeFrame: 3 months
measure: change from baseline of thermal and vibration thresholds
timeFrame: 3 months
Other outcomes:
Locations:
city: Créteil
country: France
facility: Hôpital Henri Mondor
Study officials:
affiliation: Henri Mondor University Hospital
name: Alain Créange, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: