Dietetic and Hygiene Measures in Metabolic Neuropathies: the Neurodiet Study

Metabolic Syndrome X Clinical Trial

Official title:

Dietetic and Hygiene Measures in Metabolic Neuropathies: the Neurodiet Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01465620
• Other study ID #: HM01
• Status: Completed
• Phase: Phase 3
• Start date: November 2011
• Est. completion date: June 2018

Study information

• Verified date: August 2018
• Source: Henri Mondor University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Polyneuropathy
• Metabolic Syndrome X
• Nervous System Diseases
• Peripheral Nervous System Diseases
• Polyneuropathies

Intervention

Behavioral:
• hygienic-dietetic measures
Therapeutic education about hygienic-dietetic measures followed by a 5 minutes phone call per week during 3 months
• hygienic-dietetic measures
Therapeutic education about hygienic-dietetic measures followed by only one phone call

Locations

Country	Name	City	State
France	Hôpital Henri Mondor	Créteil

Sponsors (1)

Lead Sponsor	Collaborator
Henri Mondor University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	clinical global impression of change		3 months
Secondary	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
Secondary	change from baseline of thermal and vibration thresholds		3 months