Clinical trial NCT01607684: Pilot Study to Evaluate Magnetic Marker Imaging on Diabetic Polyneuropathy and Gastroparesis
Official title: Pilot Study to Evaluate Magnetic Marker Imaging on Diabetic Polyneuropathy and Gastroparesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Polyneuropathy
Diabetic Gastroparesis
Diabetes Mellitus
Lead sponsor: Martin-Luther-Universität Halle-Wittenberg
Sponsor class: OTHER
First posted: 2012-05-30
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Frequency of gastric peristalsis
timeFrame: 4 hours
Secondary outcomes:
measure: Intensity of gastric peristaltic waves
timeFrame: 4 hours
measure: 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)
timeFrame: 4 hours
measure: Influence of age on parameters of diabetic polyneuropathy measurable by magnetic marker imaging
timeFrame: 4 hours
Other outcomes:
Locations:
city: Halle
country: Germany
facility: Universitätsklinikum Halle
Study officials:
affiliation: Martin-Luther-Universität Halle-Wittenberg
name: Thomas Seufferlein, MD
role: PRINCIPAL_INVESTIGATOR
References: