Dietetic and Hygiene Measures in Metabolic Neuropathies: the Neurodiet Study

Phase 3

Completed

• Conditions: Metabolic Syndrome X; Diabetic Polyneuropathy; Peripheral Nervous System Diseases
• Interventions: Behavioral: hygienic-dietetic measures

• Registration Number: NCT01465620
• Lead Sponsor: Henri Mondor University Hospital

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.

Study Timeline

• Study First Submitted: 2011-10-31
• Study Start: 2011-11
• Study First Submitted QC: 2011-11-02
• Study First Posted: 2011-11-06
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-28
• Last Update Posted: 2018-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coaching	hygienic-dietetic measures	active hygienic-dietetic coaching
control	hygienic-dietetic measures	reference hygienic-dietetic recommendations

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Hôpital Henri Mondor; 🇫🇷 Créteil, France