Dietetic and Hygiene Measures in Metabolic Neuropathies: the Neurodiet Study

NCT ID: NCT01465620

Last Updated: 2018-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2018-06-30

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:

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.

Conditions

Peripheral Nervous System Diseases; Diabetic Polyneuropathy; Metabolic Syndrome X

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Coaching

active hygienic-dietetic coaching

Group Type: EXPERIMENTAL

hygienic-dietetic measures

Intervention Type: BEHAVIORAL

Therapeutic education about hygienic-dietetic measures followed by a 5 minutes phone call per week during 3 months

control

reference hygienic-dietetic recommendations

Group Type: ACTIVE_COMPARATOR

hygienic-dietetic measures

Intervention Type: BEHAVIORAL

Therapeutic education about hygienic-dietetic measures followed by only one phone call

Interventions

hygienic-dietetic measures

Therapeutic education about hygienic-dietetic measures followed by a 5 minutes phone call per week during 3 months

Intervention Type: BEHAVIORAL

hygienic-dietetic measures

Therapeutic education about hygienic-dietetic measures followed by only one phone call

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henri Mondor University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sophie Ng Wing Tin

Investigator, clinical doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alain Créange, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Henri Mondor University Hospital

Locations

Hôpital Henri Mondor

Créteil, , France

Countries

France

Other Identifiers

HM01

Identifier Type: -

Identifier Source: org_study_id