Diabetic PolyneuropathyPhase 2NCT01607684
Pilot Study to Evaluate Magnetic Marker Imaging on Diabetic Polyneuropathy and Gastroparesis
A Phase 2 study testing Magnetic Marker Imaging (MMI) with Magma 3D system in people with Diabetic Polyneuropathy and Diabetic Gastroparesis, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether Magnetic Marker Monitoring is an appropriate opportunity to diagnose and to quantify a suspicious gastroparesis in subjects with diabetic polyneuropathy. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Polyneuropathy, Diabetic Gastroparesis, Diabetes Mellitus
- What is being tested?
- Magnetic Marker Imaging (MMI) with Magma 3D system
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2012to Sep 2012
- Phase
- Phase 2
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age > 50 years
- written informed consent
- Diabetes mellitus (only Diabetes mellitus group)
- Symptoms of diabetic gastroparesis with respect to nausea, postprandial fullness, abdominal pain, nausea, vomiting, abdominal bloating, early satiety, erratic blood glucose levels and weight loss evaluated by a standardized questionnaire (only Diabetes mellitus group)
- actually measured HbA1c (only Diabetes mellitus group)
Who cannot join
- Subject who is pregnant or breast feeding.
- Subject unwilling or unable to comply with study requirements.
- Any investigational agent or participation in another clinical trial within 28 days prior to randomization
- Any kind of disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures.
- History of any medical condition that may increase the risks associated with study participation or may interfere with the interpretation of the study results.
- Known allergy to the investigational product, to any of its excipients
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- Active inflammatory bowel disease, serious gastric ulceration or other bowel diseases like e.g. coeliac disease
- Implanted cardiac cardioverter-defibrillator or cardiac pacemaker
- Stenosis or stricture of gastrointestinal tract or any surgery in this region except for cholecystectomy or appendectomy
- Long-term medication with drug, that influence gastrointestinal motility (opiate, opioids, erythromycin, metoclopramide, laxatives) < 3 days before randomisation and before magnetic marker monitoring
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether Magnetic Marker Monitoring is an appropriate opportunity to diagnose and to quantify a suspicious gastroparesis in subjects with diabetic polyneuropathy.
- Being tested
- Magnetic Marker Imaging (MMI) with Magma 3D system
- Medical subject headings
- Diabetic Neuropathies, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Marker Imaging (MMI) with Magma 3D systemDevice
Magnetic Marker Imaging (MMI). It comprises of a high-resolution three-dimensional detector system, that detects passively and continuously the magnetic field of a magnetic marker capsule (1g, 6x12mm), which is taken orally by the subject. Changes in frequency, intensity and duration of oscillating marker movements allow us to delineate migrating gastric motor complexes. The Magnetic Marker Imaging takes up to 4 h in which the patient lies in a bed. Short interruptions (e.g. to visit the restroom) during this 4 h period are possible.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes mellitus group | Other | Subjects with Diabetes mellitus and symptoms of diabetic gastroparesis Receives: Device: Magnetic Marker Imaging (MMI) with Magma 3D system |
| Control group | Other | Healthy volunteers as matched pairs according to gender and age Receives: Device: Magnetic Marker Imaging (MMI) with Magma 3D system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of gastric peristalsis
Measured: 4 hours
Secondary outcomes (3)
Intensity of gastric peristaltic waves
Measured: 4 hours
Correlation with other parameters of diabetic polyneuropathy (nausea, postprandial fullness, abdominal pain, nausea, vomiting, abdominal bloating, early satiety, erratic blood glucose levels and weight loss evaluated by a standardized questionnaire)
Measured: 4 hours
Influence of age on parameters of diabetic polyneuropathy measurable by magnetic marker imaging
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2012 (estimated)
- Study startJan 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic PolyneuropathyStudies 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 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martin-Luther-Universität Halle-Wittenberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. med. Thomas Seufferlein, Martin-Luther-Universität Halle-Wittenberg
- Investigators
- Thomas Seufferlein, MD, Principal investigator, Martin-Luther-Universität Halle-Wittenberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01607684
- Sponsor's protocol ID
- PAREMAG
- Other IDs
- CIV-11-05-000321
- Status last verified
- Sep 2012
- First submitted
- 20 May 2012
- Last updated
- 5 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate Magnetic Marker Imaging on Diabetic Polyneuropathy and Gastroparesis
- ClinicalTrials.gov ID
- NCT01607684
- Acronym / sponsor ID
- PAREMAG
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Martin-Luther-Universität Halle-WittenbergUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 30 May 2012 (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.
The purpose of this study is to determine whether Magnetic Marker Monitoring is an appropriate opportunity to diagnose and to quantify a suspicious gastroparesis in subjects with diabetic polyneuropathy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes mellitus group | Other | Device: Magnetic Marker Imaging (MMI) with Magma 3D systemSubjects with Diabetes mellitus and symptoms of diabetic gastroparesis |
| Control group | Other | Device: Magnetic Marker Imaging (MMI) with Magma 3D systemHealthy volunteers as matched pairs according to gender and age |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age > 50 years
- written informed consent
- Diabetes mellitus (only Diabetes mellitus group)
- Symptoms of diabetic gastroparesis with respect to nausea, postprandial fullness, abdominal pain, nausea, vomiting, abdominal bloating, early satiety, erratic blood glucose levels and weight loss evaluated by a standardized questionnaire (only Diabetes mellitus group)
- actually measured HbA1c (only Diabetes mellitus group)
Key exclusion criteria (10 listed)
- Subject who is pregnant or breast feeding.
- Subject unwilling or unable to comply with study requirements.
- Any investigational agent or participation in another clinical trial within 28 days prior to randomization
- Any kind of disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures.
- History of any medical condition that may increase the risks associated with study participation or may interfere with the interpretation of the study results.
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 |
|---|---|---|
| Magnetic Marker Imaging (MMI) with Magma 3D systemMagnetic Marker Imaging (MMI). It comprises of a high-resolution three-dimensional detector system, that detects passively and continuously the magnetic field of a magnetic marker capsule (1g, 6x12mm), which is taken orally by the subject. Changes in frequency, intensity and duration of oscillating marker movements allow us to delineate migrating gastric motor complexes. The Magnetic Marker Imaging takes up to 4 h in which the patient lies in a bed. Short interruptions (e.g. to visit the restroom) during this 4 h period are possible. | Device | Control group, Diabetes mellitus group |
Primary outcome
Frequency of gastric peristalsis
Time frame: 4 hours
3 secondary outcomes
Intensity of gastric peristaltic waves
Time frame: 4 hours
Correlation with other parameters of diabetic polyneuropathy (nausea, postprandial fullness, abdominal pain, nausea, vomiting, abdominal bloating, early satiety, erratic blood glucose levels and weight loss evaluated by a standardized questionnaire)
Time frame: 4 hours
Influence of age on parameters of diabetic polyneuropathy measurable by magnetic marker imaging
Time frame: 4 hours
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 5 Sep 2012.
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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.
Thomas Seufferlein, MD principal investigator
Martin-Luther-Universität Halle-Wittenberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Magnetic Marker Imaging (MMI) with Magma 3D system in people with Diabetic Polyneuropathy and Diabetic Gastroparesis, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
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 10 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 5 Sep 2012. 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 Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Frequency of gastric peristalsis (time frame: 4 hours). 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 5 Sep 2012.