Dietetic and Hygiene Measures in Metabolic Neuropathies: the Neurodiet Study
Primary Purpose
Peripheral Nervous System Diseases, Diabetic Polyneuropathy, Metabolic Syndrome X
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
hygienic-dietetic measures
hygienic-dietetic measures
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Nervous System Diseases focused on measuring Peripheral Nervous System Diseases, Diabetic Polyneuropathy, Metabolic Syndrome X
Eligibility 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
Sites / Locations
- Hôpital Henri Mondor
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Coaching
control
Arm Description
active hygienic-dietetic coaching
reference hygienic-dietetic recommendations
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
clinical global impression of change
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
change from baseline of thermal and vibration thresholds
Full Information
NCT ID
NCT01465620
First Posted
October 31, 2011
Last Updated
August 28, 2018
Sponsor
Henri Mondor University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01465620
Brief Title
Dietetic and Hygiene Measures in Metabolic Neuropathies: the Neurodiet Study
Official Title
Dietetic and Hygiene Measures in Metabolic Neuropathies: the Neurodiet Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henri Mondor University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Nervous System Diseases, Diabetic Polyneuropathy, Metabolic Syndrome X
Keywords
Peripheral Nervous System Diseases, Diabetic Polyneuropathy, Metabolic Syndrome X
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Coaching
Arm Type
Experimental
Arm Description
active hygienic-dietetic coaching
Arm Title
control
Arm Type
Active Comparator
Arm Description
reference hygienic-dietetic recommendations
Intervention Type
Behavioral
Intervention Name(s)
hygienic-dietetic measures
Intervention Description
Therapeutic education about hygienic-dietetic measures followed by a 5 minutes phone call per week during 3 months
Intervention Type
Behavioral
Intervention Name(s)
hygienic-dietetic measures
Intervention Description
Therapeutic education about hygienic-dietetic measures followed by only one phone call
Primary Outcome Measure Information:
Title
Change from Baseline in NTSS6 score at 3 months
Description
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)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
clinical global impression of change
Time Frame
3 months
Title
change from baseline of sensory nerve action potential and sensory and motor nerve velocity
Description
change from baseline of sensory nerve action potential and sensory and motor nerve velocity at 3 months
Time Frame
3 months
Title
change from baseline of thermal and vibration thresholds
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain Créange, MD PhD
Organizational Affiliation
Henri Mondor University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Henri Mondor
City
Créteil
ZIP/Postal Code
94010
Country
France
12. IPD Sharing Statement
Learn more about this trial
Dietetic and Hygiene Measures in Metabolic Neuropathies: the Neurodiet Study
We'll reach out to this number within 24 hrs