Metabolic Syndrome X Clinical Trial
Official title:
Dietetic and Hygiene Measures in Metabolic Neuropathies: the Neurodiet Study
NCT number | NCT01465620 |
Other study ID # | HM01 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | November 2011 |
Est. completion date | June 2018 |
Verified date | August 2018 |
Source | Henri Mondor University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 8 |
Est. completion date | June 2018 |
Est. primary completion date | June 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Henri Mondor | Créteil |
Lead Sponsor | Collaborator |
---|---|
Henri Mondor University Hospital |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline in NTSS6 score at 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) | 3 months | |
Secondary | clinical global impression of change | 3 months | ||
Secondary | change from baseline of sensory nerve action potential and sensory and motor nerve velocity | change from baseline of sensory nerve action potential and sensory and motor nerve velocity at 3 months | 3 months | |
Secondary | change from baseline of thermal and vibration thresholds | 3 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
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