Dietetic and Hygiene Measures in Metabolic Neuropathies: the Neurodiet Study

NCT01465620 | Completed Phase 3

• 1 other identifier: HM01
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Nervous System Diseases; Diabetic Polyneuropathy; Metabolic Syndrome X

Keywords

Peripheral Nervous System Diseases; Diabetic Polyneuropathy; Metabolic Syndrome X

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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 thermal and vibration thresholds

  3 months

Study Arms (2)

Coaching

EXPERIMENTAL

active hygienic-dietetic coaching

Behavioral: hygienic-dietetic measures

control

ACTIVE COMPARATOR

reference hygienic-dietetic recommendations

Behavioral: hygienic-dietetic measures

Interventions

hygienic-dietetic measures BEHAVIORAL

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

Coaching

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henri Mondor University Hospital: lead

Study Sites (1)

Hôpital Henri Mondor

Créteil, 94010, France

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Diabetic Neuropathies; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Alain Créange, MD PhD

  Henri Mondor University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator, clinical doctor

Study Record Dates

• First Submitted: October 31, 2011
• First Posted: November 7, 2011
• Study Start: November 1, 2011
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: August 29, 2018

Record last verified: 2018-08

Locations

FR (1)