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

Martin-Luther-Universität Halle-Wittenberg

Status and phase

Completed

Phase 2

Conditions

Diabetic Gastroparesis

Diabetes Mellitus

Diabetic Polyneuropathy

Treatments

Device: Magnetic Marker Imaging (MMI) with Magma 3D system

Study type

Interventional

Funder types

Other

Identifiers

NCT01607684

CIV-11-05-000321 (Other Identifier)

PAREMAG

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

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