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Dietetic and Hygiene Measures in Metabolic Neuropathies: the Neurodiet Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01465620
Recruitment Status : Completed
First Posted : November 6, 2011
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Sophie Ng Wing Tin, Henri Mondor University Hospital

Study Description
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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 on neuropathic symptoms and neurophysiological parameters of patients with metabolic neuropathies.

Condition or disease Intervention/treatment Phase
Peripheral Nervous System Diseases Diabetic Polyneuropathy Metabolic Syndrome X Behavioral: hygienic-dietetic measures Phase 3

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 effect of physical training and diet education on neuropathic symptoms and neurophysiological parameters
  2. 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dietetic and Hygiene Measures in Metabolic Neuropathies: the Neurodiet Study
Study Start Date : November 2011
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

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


Locations
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France
Hôpital Henri Mondor
Créteil, France, 94010
Sponsors and Collaborators
Henri Mondor University Hospital
Investigators
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Principal Investigator: Alain Créange, MD PhD Henri Mondor University Hospital
More Information
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Responsible Party: Sophie Ng Wing Tin, Investigator, clinical doctor, Henri Mondor University Hospital
ClinicalTrials.gov Identifier: NCT01465620    
Other Study ID Numbers: HM01
First Posted: November 6, 2011    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Keywords provided by Sophie Ng Wing Tin, Henri Mondor University Hospital:
Peripheral Nervous System Diseases
Diabetic Polyneuropathy
Metabolic Syndrome X
Additional relevant MeSH terms:
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Nervous System Diseases
Polyneuropathies
Diabetic Neuropathies
Peripheral Nervous System Diseases
Microvascular Angina
Metabolic Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
 Neuromuscular Diseases
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases