Dietetic and Hygiene Measures in Metabolic Neuropathies: the Neurodiet Study

Sponsor

Henri Mondor University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01465620

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

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.

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

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 Design

Study Type:

Interventional

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 :

Nov 1, 2011

Actual Primary Completion Date :

Jun 1, 2018

Actual Study Completion Date :

Jun 1, 2018

Arms and Interventions

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

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

Primary Outcome Measures

Change from Baseline in NTSS6 score at 3 months [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 [3 months]
change from baseline of sensory nerve action potential and sensory and motor nerve velocity [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 [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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