Dietetic and Hygiene Measures in Metabolic Neuropathies: the Neurodiet Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Henri Mondor University Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Sophie Ng Wing Tin, Henri Mondor University Hospital
ClinicalTrials.gov Identifier:
NCT01465620
First received: October 31, 2011
Last updated: November 2, 2011
Last verified: November 2011
  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

Resource links provided by NLM:


Further study details as provided by Henri Mondor University Hospital:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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:

  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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01465620

Contacts
Contact: Alain Créange, MD PhD +33 1 49 81 23 10 alain.creange@hmn.ap-hop-paris.fr

Locations
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         
Sponsors and Collaborators
Henri Mondor University Hospital
Investigators
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
Syndrome
Metabolic Syndrome X
Polyneuropathies
Diabetic Neuropathies
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Neuromuscular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 18, 2014