Plain English Summary
Background and study aims
Gastroparesis is a motility disorder where the stomach can't empty itself in the normal way and food passes through the stomach more slowly than usual. It is an important complication of diabetes. Motility disorders are underdiagnosed and can lead to unexplained hypoglycemia (low blood sugar). Currently, diagnostic options are limited, and all established methods have disadvantages. The 3D-MAGMA system is capable of reliably measuring stomach and small intestine motility. The aim of this study is to find out whether 3D-MAGMA is able to detect changes in intestinal motility in people with type 2 diabetes and healthy volunteers.
Who can participate?
Patients with type 2 diabetes and healthy volunteers, aged 18-85
What does the study involve?
The participants are positioned in a chair with the 3D-MAGMA-unit attached to it. A magnet is orally administered with 70 ml of water after the recording is started. The time taken for the magnet to pass through the stomach and small intestine is recorded. If the marker stays in the stomach, the measurement is stopped after a minimum of three hours.
What are the possible benefits and risks of participating?
A possible benefit to the participants would be the detection of a gastroparesis which requires medical treatment. 3D-MAGMA is a low risk measuring system. The magnet itself is coated by an inert synthetic material and does not interact with its surroundings. As the marker is magnetic it has to be excreted before having an MRI examination.
Where is the study run from?
Friedrich-Schiller-Universität (Germany)
When is the study starting and how long is it expected to run for?
May 2011 to January 2019
Who is funding the study?
University Hospital Jena (Germany)
Who is the main contact?
Mr Veit Yves Pascal Jacob
Trial website
Contact information
Type
Scientific
Primary contact
Mr Veit Yves Pascal Jacob
ORCID ID
http://orcid.org/0000-0001-9216-3226
Contact details
Klinik für Innere Medizin IV
Gastroenterologie
Hepatologie und Infektiologie
Universitätsklinikum Jena
Friedrich Schiller Universität Jena
Am Klinikum 1
Jena
07747
Germany
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
1.1
Study information
Scientific title
Measuring people with type 2 diabetes using the high-resolution three-dimensional magnetic detector system 3D-MAGMA - compared to young healthy volunteers to detect changes in gastic and small bowl motility
Acronym
Study hypothesis
The aim of the current trial is to determine if 3D-MAGMA is able to detect changes in gastric and small bowel motility in patients with type 2 diabetes compared to healthy controls.
Ethics approval
Local ethics board of Friedrich-Schiller-University Jena, 12/08/2011, ref: 3179- 07/11
Study design
Single-centre two-arm open trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
People with type 2 diabetes using insulin and peripheral neuropathy
Intervention
The intervention was an incorporated magnetic capsule detected with the high-resolution three-dimensional magnetic detector system 3D-MAGMA. This system is able to track the position and movement of the marker with high accuracy.
Each person was measured once. The measurement took place in the former outpatients department of the KIM III (Department of Internal Medicine III, Endocrinology and Metabolic Diseases University Hospital Jena). The procedure was started between 8:00am and 9:30 am, after fasting for a minimum of 8 hours. Height, weight, blood glucose level, HbA1c, blood pressure and heart rate were all measured prior to the procedure by a study nurse, and a relevant symptomatic history was obtained with a standardized interview (nausea, vomiting, sustained bloating and abdominal and epigastric pain). The whole procedure was supervised by a postgraduate student.
More detailed information regarding the 3D-MAGMA is available at: https://www.ncbi.nlm.nih.gov/pubmed/19095766
Intervention type
Device
Phase
Drug names
Primary outcome measure
Residence time (min) of the capsule in the stomach measured by 3D-MAGMA
Secondary outcome measures
1. Residence time (min) of the capsule in the duodenum measured by 3D-MAGMA
2. Residence time (min) of the capsule in the first 50 cm of the jejunum measured by 3D-MAGMA
Overall trial start date
12/05/2011
Overall trial end date
01/01/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age 18-85 years
2. NSS >4/10 and NDS >6/10
3. Blood glucose 4-12 mmol/l before testing
4. Written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20
Total final enrolment
37
Participant exclusion criteria
1. Surgery of stomach or small bowel
2. Opioids, erythromycin, prokinetic agents, L-dopa, ß-agonists, benzodiazepines, ondansetron, tricyclic antidepressives, atropine
3. Eating disorder, portal hypertension, gastric cancer, systemic sclerosis, myotonic dystrophy
4. Pregnancy
5. Implanted cardiac pacemaker/defibrillator
Recruitment start date
12/03/2013
Recruitment end date
02/07/2014
Locations
Countries of recruitment
Germany
Trial participating centre
Friedrich-Schiller-Universität
Department of Internal Medicine IV
(Gastroenterology, Hepatology and Infectious Diseases)
Am Klinikum 1
Jena
07747
Germany
Sponsor information
Organisation
University Hospital Jena
Sponsor details
Klinik für Innere Medizin IV
(Gastroenterologie
Hepatologie und Infektiologie)
Universitätsklinikum Jena
Friedrich Schiller Universität Jena
Am Klinikum 1
Jena
07747
Germany
+49 (0)3641 9324221
Gastro@med.uni-jena.de
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Universitätsklinikum Jena
Alternative name(s)
Jena University Hospital, UKJ
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
Germany
Results and Publications
Publication and dissemination plan
Additional documents such as study protocol and statistical analysis plan are available upon request. Planned publication in a high-impact peer reviewed journal within the next 12 months.
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Mr Veit Yves Pascal Jacob.
Intention to publish date
15/02/2021
Participant level data
Available on request
Basic results (scientific)
Publication list
2020 results in https://pubmed.ncbi.nlm.nih.gov/32557505/ (added 01/07/2020)