NCT01465620

Dietetic and Hygiene Measures in Metabolic Neuropathies: the Neurodiet Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Henri Mondor University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral Nervous System Diseases
• Diabetic Polyneuropathy
• Metabolic Syndrome X

Interventions

Type	Name	Description
BEHAVIORAL	hygienic-dietetic measures	Therapeutic education about hygienic-dietetic measures followed by a 5 minutes phone call per week during 3 months
BEHAVIORAL	hygienic-dietetic measures	Therapeutic education about hygienic-dietetic measures followed by only one phone call

Timeline

• Start date: 2011-11-01
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2011-11-07
• Last updated: 2018-08-29

Locations

1 site across 1 country: France