Dietetic and Hygiene Measures in Metabolic Neuropathies: the Neurodiet Study

Last updated: August 28, 2018
Sponsor: Henri Mondor University Hospital
Overall Status: Completed

Phase

3

Condition

Metabolic Syndrome

Hypertriglyceridemia

Diabetic Neuropathy

Treatment

N/A

Clinical Study ID

NCT01465620
HM01
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Clinical and neurophysiologic neuropathy (clinical signs of neuropathy and at leasttwo low sensory nerve action potential (superficial peroneal and sural nerves))

  • Metabolic disorder: Glucose disorder (diabetes mellitus or glucose intolerance) ormetabolic 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

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

Study Design

Total Participants: 8
Study Start date:
November 01, 2011
Estimated Completion Date:
June 30, 2018

Study 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.

Connect with a study center

  • Hôpital Henri Mondor

    Créteil, 94010
    France

    Site Not Available

  • Hôpital Henri Mondor

    Créteil, 94010
    France

    Site Not Available

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