Condition category
Nutritional, Metabolic, Endocrine
Date applied
10/08/2017
Date assigned
15/08/2017
Last edited
15/08/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

ClinicalTrials.gov number

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 measures

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

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

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

http://www.kim4.uniklinikum-jena.de

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

academic

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

15/08/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes