search
Back to results

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
Henri Mondor University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
October 31, 2011
Last Updated
August 28, 2018
Sponsor
Henri Mondor University Hospital
search

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