Dietetic and Hygiene Measures in Metabolic Neuropathies: the Neurodiet Study

Henri Mondor University Hospital

Status and phase: Completed; Phase 3

Conditions: Peripheral Nervous System Diseases; Diabetic Polyneuropathy; Metabolic Syndrome X

Treatments: Behavioral: hygienic-dietetic measures

Study type: Interventional

Funder types: Other

Identifiers

NCT01465620

HM01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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8 participants in 2 patient groups

Coaching

Experimental group

Description:

active hygienic-dietetic coaching

Treatment:

Behavioral: hygienic-dietetic measures

Behavioral: hygienic-dietetic measures

control

Active Comparator group

Description:

reference hygienic-dietetic recommendations

Treatment:

Behavioral: hygienic-dietetic measures

Behavioral: hygienic-dietetic measures