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OpenTrials
Completed

NCT Number: NCT01465620

Dietetic and Hygiene Measures in Metabolic Neuropathies: the Neurodiet Study

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.

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Key information

About this study

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:

  • the effect of physical training and diet education on neuropathic symptoms and neurophysiological parameters
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hygienic-dietetic measures

Behavioral

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

Primary outcomes

  1. Change from Baseline in NTSS6 score at 3 months

    Time frame: 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)

Secondary outcomes

  1. clinical global impression of change

    Time frame: 3 months

  2. change from baseline of sensory nerve action potential and sensory and motor nerve velocity

    Time frame: 3 months

    change from baseline of sensory nerve action potential and sensory and motor nerve velocity at 3 months

  3. change from baseline of thermal and vibration thresholds

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Henri Mondor University Hospital

Other

Registry information

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Nov 7, 2011
Registry last updated
Aug 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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