Status:
COMPLETED
Dietetic and Hygiene Measures in Metabolic Neuropathies: the Neurodiet Study
Lead Sponsor:
Henri Mondor University Hospital
Conditions:
Peripheral Nervous System Diseases
Diabetic Polyneuropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
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 ef...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2018
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01465620
Start Date
November 1 2011
End Date
June 1 2018
Last Update
August 29 2018
Active Locations (1)
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1
Hôpital Henri Mondor
Créteil, France, 94010