Pilot Study to Evaluate Magnetic Marker Imaging on Diabetic Polyneuropathy and Gastroparesis

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Study to Evaluate Magnetic Marker Imaging on Diabetic Polyneuropathy and Gastroparesis

Conditions
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Diabetic Polyneuropathy, Diabetic Gastroparesis, Diabetes Mellitus

Intervention / Treatment
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* Device: Magnetic Marker Imaging (MMI) with Magma 3D system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Diabetes mellitus group<br>Subjects with Diabetes mellitus and symptoms of diabetic gastroparesis | Device: Magnetic Marker Imaging (MMI) with Magma 3D system<br>* 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.<br>|
| Other: Control group<br>Healthy volunteers as matched pairs according to gender and age | Device: Magnetic Marker Imaging (MMI) with Magma 3D system<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of gastric peristalsis |  | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 4 hours | 
| Influence of age on parameters of diabetic polyneuropathy measurable by magnetic marker imaging |  | 4 hours |