Pilot Study to Evaluate Magnetic Marker Imaging on Diabetic Polyneuropathy and Gastroparesis

Diabetes Mellitus Clinical Trial

Official title:

Pilot Study to Evaluate Magnetic Marker Imaging on Diabetic Polyneuropathy and Gastroparesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01607684
• Other study ID #: PAREMAG
• Secondary ID: CIV-11-05-000321
• Status: Completed
• Phase: Phase 2
• First received: May 20, 2012
• Last updated: September 3, 2012
• Start date: January 2012
• Est. completion date: September 2012

Study information

• Verified date: September 2012
• Source: Martin-Luther-Universität Halle-Wittenberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether Magnetic Marker Monitoring is an appropriate opportunity to diagnose and to quantify a suspicious gastroparesis in subjects with diabetic polyneuropathy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• age > 50 years

• written informed consent

• Diabetes mellitus (only Diabetes mellitus group)

• Symptoms of diabetic gastroparesis with respect to nausea, postprandial fullness, abdominal pain, nausea, vomiting, abdominal bloating, early satiety, erratic blood glucose levels and weight loss evaluated by a standardized questionnaire (only Diabetes mellitus group)

• actually measured HbA1c (only Diabetes mellitus group)

Exclusion Criteria:

• Subject who is pregnant or breast feeding.

• Subject unwilling or unable to comply with study requirements.

• Any investigational agent or participation in another clinical trial within 28 days prior to randomization

• Any kind of disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures.

• History of any medical condition that may increase the risks associated with study participation or may interfere with the interpretation of the study results.

• Known allergy to the investigational product, to any of its excipients

• Active inflammatory bowel disease, serious gastric ulceration or other bowel diseases like e.g. coeliac disease

• Implanted cardiac cardioverter-defibrillator or cardiac pacemaker

• Stenosis or stricture of gastrointestinal tract or any surgery in this region except for cholecystectomy or appendectomy

• Long-term medication with drug, that influence gastrointestinal motility (opiate, opioids, erythromycin, metoclopramide, laxatives) < 3 days before randomisation and before magnetic marker monitoring

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Gastroparesis
• Diabetic Neuropathies
• Diabetic Polyneuropathy
• Gastroparesis
• Polyneuropathies

Intervention

Device:
• Magnetic Marker Imaging (MMI) with Magma 3D system
Magnetic Marker Imaging (MMI). It comprises of a high-resolution three-dimensional detector system, that detects passively and continuously the magnetic field of a magnetic marker capsule (1g, 6x12mm), which is taken orally by the subject. Changes in frequency, intensity and duration of oscillating marker movements allow us to delineate migrating gastric motor complexes. The Magnetic Marker Imaging takes up to 4 h in which the patient lies in a bed. Short interruptions (e.g. to visit the restroom) during this 4 h period are possible.

Locations

Country	Name	City	State
Germany	Universitätsklinikum Halle	Halle

Sponsors (1)

Lead Sponsor	Collaborator
Martin-Luther-Universität Halle-Wittenberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of gastric peristalsis		4 hours	No
Secondary	Intensity of gastric peristaltic waves		4 hours	No
Secondary	Correlation with other parameters of diabetic polyneuropathy (nausea, postprandial fullness, abdominal pain, nausea, vomiting, abdominal bloating, early satiety, erratic blood glucose levels and weight loss evaluated by a standardized questionnaire)		4 hours	No
Secondary	Influence of age on parameters of diabetic polyneuropathy measurable by magnetic marker imaging		4 hours	No