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| ID | Type | Description | Link |
|---|---|---|---|
| CIV-11-05-000321 | Other Identifier | European Databank on Medical Devices - EUDAMED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetes mellitus group | Other | Subjects with Diabetes mellitus and symptoms of diabetic gastroparesis |
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| Control group | Other | Healthy volunteers as matched pairs according to gender and age |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Marker Imaging (MMI) with Magma 3D system | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of gastric peristalsis | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Intensity of gastric peristaltic waves | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Seufferlein, MD | Martin-Luther-Universität Halle-Wittenberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Halle | Halle | 06120 | Germany |
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| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
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|
| 4 hours |
| Influence of age on parameters of diabetic polyneuropathy measurable by magnetic marker imaging | 4 hours |
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |