The high-resolution three-dimensional magnetic detector system 3D-MAGMA accurately measures gastric and small bowel motility in people with type 2 diabetes with neuropathy

ISRCTN ISRCTN81917128
DOI https://doi.org/10.1186/ISRCTN81917128
Secondary identifying numbers 1.1
Submission date
10/08/2017
Registration date
15/08/2017
Last edited
01/07/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Mr Veit Yves Pascal Jacob
Scientific

Klinik für Innere Medizin IV
Gastroenterologie, Hepatologie und Infektiologie
Universitätsklinikum Jena, Friedrich Schiller Universität Jena
Am Klinikum 1
Jena
07747
Germany

ORCiD logoORCID ID 0000-0001-9216-3226

Study information

Study designSingle-centre two-arm open trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleMeasuring 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 objectivesThe 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(s)Local ethics board of Friedrich-Schiller-University Jena, 12/08/2011, ref: 3179- 07/11
Health condition(s) or problem(s) studiedPeople with type 2 diabetes using insulin and peripheral neuropathy
InterventionThe 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 typeDevice
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measureResidence time (min) of the capsule in the stomach measured by 3D-MAGMA
Secondary outcome measures1. 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 study start date12/05/2011
Completion date01/01/2019

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit85 Years
SexBoth
Target number of participants20
Total final enrolment37
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment12/03/2013
Date of final enrolment02/07/2014

Locations

Countries of recruitment

  • Germany

Study participating centre

Friedrich-Schiller-Universität
Department of Internal Medicine IV
(Gastroenterology, Hepatology and Infectious Diseases)
Am Klinikum 1
Jena
07747
Germany

Sponsor information

University Hospital Jena
Hospital/treatment centre

Klinik für Innere Medizin IV
(Gastroenterologie, Hepatologie und Infektiologie)
Universitätsklinikum Jena, Friedrich Schiller Universität Jena
Am Klinikum 1
Jena
07747
Germany

Phone +49 (0)3641 9324221
Email Gastro@med.uni-jena.de
Website http://www.kim4.uniklinikum-jena.de
ROR logo "ROR" https://ror.org/035rzkx15

Funders

Funder type

Hospital/treatment centre

Universitätsklinikum Jena
Private sector organisation / Universities (academic only)
Alternative name(s)
Jena University Hospital, UKJ
Location
Germany

Results and Publications

Intention to publish date15/02/2021
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planAdditional 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 planThe datasets generated during and/or analysed during the current study are/will be available upon request from Mr Veit Yves Pascal Jacob.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/06/2020 01/07/2020 Yes No

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