Condition category
Nutritional, Metabolic, Endocrine
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

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



Primary contact

Mr Veit Yves Pascal Jacob


Contact details

Klinik für Innere Medizin IV
Hepatologie und Infektiologie
Universitätsklinikum Jena
Friedrich Schiller Universität Jena
Am Klinikum 1

Additional identifiers

EudraCT number

Nil known number

Nil known

Protocol/serial number


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


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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use contact details to request a participant information sheet


People with type 2 diabetes using insulin and peripheral neuropathy


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:

Intervention type



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


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




Target number of participants


Total final enrolment


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


Recruitment end date



Countries of recruitment


Trial participating centre

Department of Internal Medicine IV (Gastroenterology, Hepatology and Infectious Diseases) Am Klinikum 1

Sponsor information


University Hospital Jena

Sponsor details

Klinik für Innere Medizin IV
Hepatologie und Infektiologie)
Universitätsklinikum Jena
Friedrich Schiller Universität Jena
Am Klinikum 1
+49 (0)3641 9324221

Sponsor type

Hospital/treatment centre



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)



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


Participant level data

Available on request

Basic results (scientific)

Publication list

2020 results in (added 01/07/2020)

Publication citations

Additional files

Editorial Notes

01/07/2020: The following changes have been made: 1. Publication reference added. 2. The total final enrolment number has been added from the reference. 27/02/2019: The intention to publish date was changed from 15/08/2018 to 15/02/2021