Pilot Study to Evaluate Magnetic Marker Imaging on Diabetic Polyneuropathy and Gastroparesis
NCT ID: NCT01607684
Last Updated: 2012-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2012-01-31
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Diabetes mellitus group
Subjects with Diabetes mellitus and symptoms of diabetic gastroparesis
Magnetic Marker Imaging (MMI) with Magma 3D system
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.
Control group
Healthy volunteers as matched pairs according to gender and age
Magnetic Marker Imaging (MMI) with Magma 3D system
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.
Interventions
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Magnetic Marker Imaging (MMI) with Magma 3D system
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.
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
* 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
50 Years
ALL
Yes
Sponsors
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Martin-Luther-Universität Halle-Wittenberg
OTHER
Responsible Party
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Prof. Dr. med. Thomas Seufferlein
Prof. Dr. med.
Principal Investigators
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Thomas Seufferlein, MD
Role: PRINCIPAL_INVESTIGATOR
Martin-Luther-Universität Halle-Wittenberg
Locations
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Universitätsklinikum Halle
Halle, , Germany
Countries
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Other Identifiers
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CIV-11-05-000321
Identifier Type: OTHER
Identifier Source: secondary_id
PAREMAG
Identifier Type: -
Identifier Source: org_study_id