Dietetic and Hygiene Measures in Metabolic Neuropathies: the Neurodiet Study

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Nervous System Diseases; Metabolic Syndrome X; Diabetic Polyneuropathy
• Intervention / Treatment: Behavioral: hygienic-dietetic measures; Behavioral: hygienic-dietetic measures

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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Créteil, France, 94010
    • Hôpital Henri Mondor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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; Behavioral: hygienic-dietetic measures; Therapeutic education about hygienic-dietetic measures followed by only one phone call
Active Comparator: control; reference hygienic-dietetic recommendations	Behavioral: hygienic-dietetic measures; Therapeutic education about hygienic-dietetic measures followed by a 5 minutes phone call per week during 3 months; Behavioral: hygienic-dietetic measures; Therapeutic education about hygienic-dietetic measures followed by only one phone call

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical global impression of change		3 months
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	3 months
change from baseline of thermal and vibration thresholds		3 months

Collaborators and Investigators

• Sponsor: Henri Mondor University Hospital
• Investigators: Principal Investigator: Alain Créange, MD PhD, Henri Mondor University Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: October 31, 2011
• First Submitted That Met QC Criteria: November 2, 2011
• First Posted (Estimate): November 6, 2011

Study Record Updates

• Last Update Posted (Actual): August 29, 2018
• Last Update Submitted That Met QC Criteria: August 28, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Metabolic Syndrome X; Diabetic Polyneuropathy; Peripheral Nervous System Diseases
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Insulin Resistance; Hyperinsulinism; Angina Pectoris; Peripheral Nervous System Diseases; Metabolic Syndrome; Nervous System Diseases; Polyneuropathies; Diabetic Neuropathies; Microvascular Angina
• Other Study ID Numbers: HM01