Dietetic and Hygiene Measures in Metabolic Neuropathies: the Neurodiet Study
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| ClinicalTrials.gov Identifier: NCT01465620 |
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Recruitment Status : Unknown
Verified February 2016 by Sophie Ng Wing Tin, Henri Mondor University Hospital.
Recruitment status was: Recruiting
First Posted : November 7, 2011
Last Update Posted : February 19, 2016
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Peripheral Nervous System Diseases Diabetic Polyneuropathy Metabolic Syndrome X | Behavioral: hygienic-dietetic measures | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 40 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Official Title: | Dietetic and Hygiene Measures in Metabolic Neuropathies: the Neurodiet Study |
| Study Start Date : | November 2011 |
| Estimated Primary Completion Date : | November 2016 |
| Estimated Study Completion Date : | November 2016 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Coaching
active hygienic-dietetic coaching
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Behavioral: hygienic-dietetic measures
Therapeutic education about hygienic-dietetic measures followed by a 5 minutes phone call per week during 3 months |
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Active Comparator: control
reference hygienic-dietetic recommendations
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Behavioral: hygienic-dietetic measures
Therapeutic education about hygienic-dietetic measures followed by only one phone call |
- 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)
- clinical global impression of change [ Time Frame: 3 months ]
- 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
- change from baseline of thermal and vibration thresholds [ Time Frame: 3 months ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01465620
| Contact: Alain Créange, MD PhD | +33 1 49 81 23 10 | alain.creange@hmn.ap-hop-paris.fr |
| France | |
| Hôpital Henri Mondor | 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 |
| 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 |
| First Posted: | November 7, 2011 Key Record Dates |
| Last Update Posted: | February 19, 2016 |
| Last Verified: | February 2016 |
Keywords provided by Sophie Ng Wing Tin, Henri Mondor University Hospital:
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Peripheral Nervous System Diseases Diabetic Polyneuropathy Metabolic Syndrome X |
Additional relevant MeSH terms:
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Metabolic Syndrome X Nervous System Diseases Polyneuropathies Diabetic Neuropathies Peripheral Nervous System Diseases Insulin Resistance Hyperinsulinism |
Glucose Metabolism Disorders Metabolic Diseases Neuromuscular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases |