Peripheral Nervous System DiseasesPhase 3NCT01465620
Dietetic and Hygiene Measures in Metabolic Neuropathies: the Neurodiet Study
A Phase 3 study testing hygienic-dietetic measures in people with Peripheral Nervous System Diseases and Diabetic Polyneuropathy, run by Henri Mondor University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Nervous System Diseases, Diabetic Polyneuropathy, Metabolic Syndrome X
- What is being tested?
- hygienic-dietetic measures
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2011to Jun 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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:
- the effect of physical training and diet education on neuropathic symptoms and neurophysiological parameters
- 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.
- Being tested
- hygienic-dietetic measures
- Keywords
- Peripheral Nervous System Diseases, Diabetic Polyneuropathy, Metabolic Syndrome X
- Medical subject headings
- Peripheral Nervous System Diseases, Diabetic Neuropathies, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hygienic-dietetic measuresBehavioural
Therapeutic education about hygienic-dietetic measures followed by a 5 minutes phone call per week during 3 months
hygienic-dietetic measuresBehavioural
Therapeutic education about hygienic-dietetic measures followed by only one phone call
| Study group | Role | What they receive |
|---|---|---|
| Coaching | Experimental | active hygienic-dietetic coaching Receives: Behavioral: hygienic-dietetic measures |
| control | Active comparator | reference hygienic-dietetic recommendations Receives: Behavioral: hygienic-dietetic measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 months
Secondary outcomes (3)
clinical global impression of change
Measured: 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
Measured: 3 months
change from baseline of thermal and vibration thresholds
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Nervous System DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henri Mondor University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sophie Ng Wing Tin, Henri Mondor University Hospital
- Investigators
- Alain Créange, MD PhD, Principal investigator, Henri Mondor University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01465620
- Sponsor's protocol ID
- HM01
- Status last verified
- Aug 2018
- First submitted
- 31 Oct 2011
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietetic and Hygiene Measures in Metabolic Neuropathies: the Neurodiet Study
- ClinicalTrials.gov ID
- NCT01465620
- Acronym / sponsor ID
- HM01
- Keywords
- Peripheral Nervous System Diseases, Diabetic Polyneuropathy, Metabolic Syndrome X
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Henri Mondor University HospitalUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 7 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- the effect of physical training and diet education on neuropathic symptoms and neurophysiological parameters
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coaching | Experimental | Behavioral: hygienic-dietetic measuresactive hygienic-dietetic coaching |
| control | Active comparator | Behavioral: hygienic-dietetic measuresreference hygienic-dietetic recommendations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Non metabolic neuropathy
- Serious diabetic complication
- Renal failure (creatinine clearance<60ml/min)
- Sensory neuronopathy
- Contra-indication to physical activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hygienic-dietetic measuresTherapeutic education about hygienic-dietetic measures followed by a 5 minutes phone call per week during 3 months | Behavioural | Coaching |
| hygienic-dietetic measuresTherapeutic education about hygienic-dietetic measures followed by only one phone call | Behavioural | control |
Primary outcome
Change from Baseline in NTSS6 score at 3 months
Time frame: 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 secondary outcomes
clinical global impression of change
Time frame: 3 months
change from baseline of sensory nerve action potential and sensory and motor nerve velocity
Time frame: 3 months
change from baseline of thermal and vibration thresholds
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain Créange, MD PhD principal investigator
Henri Mondor University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing hygienic-dietetic measures in people with Peripheral Nervous System Diseases and Diabetic Polyneuropathy, run by Henri Mondor University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in NTSS6 score at 3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2018.