Dietetic and Hygiene Measures in Metabolic Neuropathies: the Neurodiet Study
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Peripheral Nervous System Diseases Diabetic Polyneuropathy Metabolic Syndrome X |
Behavioral: hygienic-dietetic measures |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) |
| Official Title: | Dietetic and Hygiene Measures in Metabolic Neuropathies: the Neurodiet Study |
- Change from Baseline in NTSS6 score at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]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)
- clinical global impression of change [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- change from baseline of sensory nerve action potential and sensory and motor nerve velocity [ Time Frame: 3 months ] [ Designated as safety issue: No ]change from baseline of sensory nerve action potential and sensory and motor nerve velocity at 3 months
- change from baseline of thermal and vibration thresholds [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Coaching
active hygienic-dietetic coaching
|
Behavioral: hygienic-dietetic measures
Therapeutic education about hygienic-dietetic measures followed by a 5 minutes phone call per week during 3 months
|
|
Active Comparator: control
reference hygienic-dietetic recommendations
|
Behavioral: hygienic-dietetic measures
Therapeutic education about hygienic-dietetic measures followed by only one phone call
|
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:
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Alain Créange, MD PhD | +33 1 49 81 23 10 | alain.creange@hmn.ap-hop-paris.fr |
| France | |
| Hôpital Henri Mondor | Not yet recruiting |
| Créteil, France, 94010 | |
| Contact: Alain Créange, MD PhD +33 1 49 81 23 10 alain.creange@hmn.ap-hop-paris.fr | |
| Principal Investigator: Alain Créange, MD PhD | |
| Principal Investigator: | Alain Créange, MD PhD | Henri Mondor University Hospital |
More Information
No publications provided
| Responsible Party: | Sophie Ng Wing Tin, Investigator, clinical doctor, Henri Mondor University Hospital |
| ClinicalTrials.gov Identifier: | NCT01465620 History of Changes |
| Other Study ID Numbers: | HM01 |
| Study First Received: | October 31, 2011 |
| Last Updated: | November 2, 2011 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Henri Mondor University Hospital:
|
Peripheral Nervous System Diseases Diabetic Polyneuropathy Metabolic Syndrome X |
Additional relevant MeSH terms:
|
Nervous System Diseases Peripheral Nervous System Diseases Polyneuropathies Diabetic Neuropathies Metabolic Syndrome X Neuromuscular Diseases Diabetes Complications |
Diabetes Mellitus Endocrine System Diseases Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013