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
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
Scientific
Klinik für Innere Medizin IV
Gastroenterologie, Hepatologie und Infektiologie
Universitätsklinikum Jena, Friedrich Schiller Universität Jena
Am Klinikum 1
Jena
07747
Germany
 ORCID ID |
0000-0001-9216-3226 |
|---|
Study information
| Study design | Single-centre two-arm open trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| 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 objectives | 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(s) | Local ethics board of Friedrich-Schiller-University Jena, 12/08/2011, ref: 3179- 07/11 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 12/05/2011 |
| Completion date | 01/01/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 85 Years |
| Sex | Both |
| Target number of participants | 20 |
| Total final enrolment | 37 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 12/03/2013 |
| Date of final enrolment | 02/07/2014 |
Locations
Countries of recruitment
- Germany
Study participating centre
(Gastroenterology, Hepatology and Infectious Diseases)
Am Klinikum 1
Jena
07747
Germany
Sponsor information
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 |
|---|---|
| Gastro@med.uni-jena.de | |
| Website | http://www.kim4.uniklinikum-jena.de |
"ROR" |
https://ror.org/035rzkx15 |
Funders
Funder type
Hospital/treatment centre
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Jena University Hospital, UKJ
- Location
- Germany
Results and Publications
| Intention to publish date | 15/02/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | The 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
