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