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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Diabetic Polyneuropathy; Diabetic Gastroparesis
• Intervention / Treatment: Device: Magnetic Marker Imaging (MMI) with Magma 3D system

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Halle, Germany, 06120
    • Universitätsklinikum Halle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Diabetes mellitus group; Subjects with Diabetes mellitus and symptoms of diabetic gastroparesis	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.
Other: Control group; Healthy volunteers as matched pairs according to gender and age	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency of gastric peristalsis	4 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Intensity of gastric peristaltic waves	4 hours
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
Influence of age on parameters of diabetic polyneuropathy measurable by magnetic marker imaging	4 hours

Collaborators and Investigators

• Sponsor: Martin-Luther-Universität Halle-Wittenberg
• Investigators: Principal Investigator: Thomas Seufferlein, MD, Martin-Luther-Universität Halle-Wittenberg

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: May 20, 2012
• First Submitted That Met QC Criteria: May 24, 2012
• First Posted (Estimate): May 30, 2012

Study Record Updates

• Last Update Posted (Estimate): September 5, 2012
• Last Update Submitted That Met QC Criteria: September 3, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Nervous System Diseases; Neurologic Manifestations; Endocrine System Diseases; Gastrointestinal Diseases; Stomach Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Paralysis; Polyneuropathies; Diabetic Neuropathies; Gastroparesis
• Other Study ID Numbers: PAREMAG; CIV-11-05-000321 (Other Identifier: European Databank on Medical Devices - EUDAMED)