Diabetic NeuropathiesNCT01180608
Functional Imaging of the Therapeutic Effect of Pregabalin in Treatment for Neuropathic Pain
A study testing MR Spectroscopy in people with Diabetic Neuropathies and Pain, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
Functional Imaging of the therapeutic effect of Pregabalin in treatment for neuropathic pain in patients with Diabetic Polyneuropathy using proton Magnetic Resonance Spectroscopy (MRS): The aim of our study is to investigate the effect of Pregabalin as a treatment for neuropathic pain in a homogeneous study… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Neuropathies, Pain
- What is being tested?
- MR Spectroscopy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2010to Sep 2012
- Phase
- Interventional
- 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
- Age ≥ 18 years
- Patients with painful DPN
- Patient willing to provide informed consent
- Type 1 or type 2 diabetes with HbA1c ≤ 11%
- Stable antidiabetic medication for 30 days prior to randomization
- Duration of painful DPN ≥ 3 months
- Visual analogue scale (VAS) score ≥ 4
Who cannot join
- Creatinine clearance ≤ 60mL/min
- Presence of other clinically significant or disabling chronic pain condition
- Active malignancy
- Evidence of an active disruptive psychiatric disorder or other known condition that might influence the perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by the investigator
- Life expectancy less than 1 year
- Existing or planned pregnancy
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- Extreme fear for entering MRI
- General contraindication for MRI (pacemaker, etc…)
- Patients participating in other clinical trials
- Age <18 years
- Prior use of potential retinotoxins
- Prohibited medications without proper wash-out period (>7days, depending on the type of medication):
- medications and supplements commonly used for relief of neuropathic pain
- antiepileptics
- antidepressants (except for stable regiments of SSRIs for treatment of anxiety or depression)
- NSAID
Trial locations and contacts
1 site in 1 country.
Belgium1 site
UZ Brussel
Brussels, Brussels Capital, 1090
Maarten Moens, MD
Maarten Moens, MD
About this study
Official title: Functional Imaging of the Therapeutic Effect of Pregabalin in Treatment for Neuropathic Pain in Patients With Diabetic Polyneuropathy Using Proton MR Spectroscopy
Functional Imaging of the therapeutic effect of Pregabalin in treatment for neuropathic pain in patients with Diabetic Polyneuropathy using proton Magnetic Resonance Spectroscopy (MRS):
The aim of our study is to investigate the effect of Pregabalin as a treatment for neuropathic pain in a homogeneous study population, using proton MRS (1H MRS) focusing on four regions of interest (bilateral thalami, rostral anterior cingulated cortex (rACC) and dominant dorsolateral prefrontal cortex (DLPC).
Read the detailed description
spectrum measurements at: thalamus left thalamus right rostral anterior cingulated cortex dominant dorsolateral prefrontal cortex
measurements: gamma-aminobutyric acid (GABA) glutamate (Glu) glutamine (Gln) N-acetylaspartate (NAA) Choline-containing compounds (Cho) Creatine plus phophocreatine (total creatine: Cr) Myo-inositiol (Ins) Choline (Cho) Glucose (Glc) Lactate (Lac)
- Conditions
- Diabetic Neuropathies, Pain
- Being tested
- MR Spectroscopy
- Keywords
- neuropathic pain, Diabetic Polyneuropathy
- Medical subject headings
- Diabetic Neuropathies, Pain, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR SpectroscopyOther
During each MR Spectroscopy session, we will measure at regions of interest (rACC, both thalami, dominant DLPC) the levels of the following biochemical substances:
- gamma-aminobutyric acid (GABA)
- glutamate (Glu)
- glutamine (Gln)
- N-acetylaspartate (NAA)
- Choline-containing compounds (Cho)
- Creatine plus phophocreatine (total creatine: Cr)
- Myo-inositiol (Ins)
- Choline (Cho)
- Glucose (Glc)
- Lactate (Lac)
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin | Active comparator | Not described Receives: Other: MR Spectroscopy |
| placebo + pregabalin | Placebo comparator | Not described Receives: Other: MR Spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
cerebral neurobiological effect of pregabaline as treatment for neuropathic pain
We will measure changes in neurotransmitter levels in the brain (gamma-aminobutyric acid (GABA) glutamate (Glu) glutamine (Gln) N-acetylaspartate (NAA) Choline-containing compounds (Cho) Creatine plus phophocreatine (total creatine: Cr) Myo-inositiol (Ins) Choline (Cho) Glucose (Glc) Lactate (Lac)) before and after treatment with pregabaline. Specific interest in ratio GABA/Gln and GABA/Glu: relationship between inhibitory and excitatory neurotransmittors
Measured: 1 year
Secondary outcomes (1)
cerebral neurobiological changes in relationship with dose dependent therapeutic effect of treatment with pregabaline
A possible dose dependent effect of treatment with Pregabalin on cerebral neurochemical changes (gamma-aminobutyric acid (GABA) glutamate (Glu) glutamine (Gln) N-acetylaspartate (NAA) Choline-containing compounds (Cho) Creatine plus phophocreatine (total creatine: Cr) Myo-inositiol (Ins) Choline (Cho) Glucose (Glc) Lactate (Lac)) and clinical effects (pain and quality of life scales) will be evaluated
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2011 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic NeuropathiesStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Moens Maarten
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01180608
- Sponsor's protocol ID
- vubmtmoensLIIRA
- Status last verified
- Aug 2010
- First submitted
- 10 Aug 2010
- Last updated
- 12 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
De Jaeger M, Goudman L, Van Schuerbeek P, De Mey J, Keymeulen B, Brouns R, Moens M. Cerebral Biochemical Effect of Pregabalin in Patients with Painful Diabetic Neuropathy: A Randomized Controlled Trial. Diabetes Ther. 2018 Aug;9(4):1591-1604. doi: 10.1007/s13300-018-0460-y. Epub 2018 Jun 27.
PubMed 29951977
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Imaging of the Therapeutic Effect of Pregabalin in Treatment for Neuropathic Pain in Patients With Diabetic Polyneuropathy Using Proton MR Spectroscopy
- ClinicalTrials.gov ID
- NCT01180608
- Acronym / sponsor ID
- vubmtmoensLIIRA
- Conditions
- Diabetic Neuropathies, Pain
- Keywords
- neuropathic pain, Diabetic Polyneuropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- Moens Maarten
- Study start
- Sep 2010
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 12 Aug 2010 (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.
Functional Imaging of the therapeutic effect of Pregabalin in treatment for neuropathic pain in patients with Diabetic Polyneuropathy using proton Magnetic Resonance Spectroscopy (MRS):
The aim of our study is to investigate the effect of Pregabalin as a treatment for neuropathic pain in a homogeneous study population, using proton MRS (1H MRS) focusing on four regions of interest (bilateral thalami, rostral anterior cingulated cortex (rACC) and dominant dorsolateral prefrontal cortex (DLPC).
Detailed description
spectrum measurements at: thalamus left thalamus right rostral anterior cingulated cortex dominant dorsolateral prefrontal cortex
measurements: gamma-aminobutyric acid (GABA) glutamate (Glu) glutamine (Gln) N-acetylaspartate (NAA) Choline-containing compounds (Cho) Creatine plus phophocreatine (total creatine: Cr) Myo-inositiol (Ins) Choline (Cho) Glucose (Glc) Lactate (Lac)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregabalin | Active comparator | Other: MR Spectroscopy |
| placebo + pregabalin | Placebo comparator | Other: MR Spectroscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Patients with painful DPN
- Patient willing to provide informed consent
- Type 1 or type 2 diabetes with HbA1c ≤ 11%
- Stable antidiabetic medication for 30 days prior to randomization
Key exclusion criteria (16 listed)
- Creatinine clearance ≤ 60mL/min
- Presence of other clinically significant or disabling chronic pain condition
- Active malignancy
- Evidence of an active disruptive psychiatric disorder or other known condition that might influence the perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by the investigator
- Life expectancy less than 1 year
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 |
|---|---|---|
| MR SpectroscopyDuring each MR Spectroscopy session, we will measure at regions of interest (rACC, both thalami, dominant DLPC) the levels of the following biochemical substances: * gamma-aminobutyric acid (GABA) * glutamate (Glu) * glutamine (Gln) * N-acetylaspartate (NAA) * Choline-containing compounds (Cho) * Creatine plus phophocreatine (total creatine: Cr) * Myo-inositiol (Ins) * Choline (Cho) * Glucose (Glc) * Lactate (Lac) | Other | Pregabalin, placebo + pregabalin |
Primary outcome
cerebral neurobiological effect of pregabaline as treatment for neuropathic pain
Time frame: 1 year
We will measure changes in neurotransmitter levels in the brain (gamma-aminobutyric acid (GABA) glutamate (Glu) glutamine (Gln) N-acetylaspartate (NAA) Choline-containing compounds (Cho) Creatine plus phophocreatine (total creatine: Cr) Myo-inositiol (Ins) Choline (Cho) Glucose (Glc) Lactate (Lac)) before and after treatment with pregabaline. Specific interest in ratio GABA/Gln and GABA/Glu: relationship between inhibitory and excitatory neurotransmittors
1 secondary outcome
cerebral neurobiological changes in relationship with dose dependent therapeutic effect of treatment with pregabaline
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2010.
- Derived from this study: PubMed 29951977De Jaeger M, Goudman L, Van Schuerbeek P, De Mey J, Keymeulen B, Brouns R, Moens M. Cerebral Biochemical Effect of Pregabalin in Patients with Painful Diabetic Neuropathy: A Randomized Controlled Trial. Diabetes Ther. 2018 Aug;9(4):1591-1604. doi: 10.1007/s13300-018-0460-y. Epub 2018 Jun 27.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR Spectroscopy in people with Diabetic Neuropathies and Pain, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 7 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 12 Aug 2010. 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 Belgium. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maarten Moens, MD (0032478884047, mtmoens@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cerebral neurobiological effect of pregabaline as treatment for neuropathic pain (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01180608, which also lists 1 linked publication.
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 12 Aug 2010.