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

Phase 2

Completed

• Conditions: Diabetic Polyneuropathy; Diabetic Gastroparesis; Diabetes Mellitus
• Interventions: Device: Magnetic Marker Imaging (MMI) with Magma 3D system

• Registration Number: NCT01607684
• Lead Sponsor: Martin-Luther-Universität Halle-Wittenberg

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-05-20
• Study First Submitted QC: 2012-05-24
• Study First Posted: 2012-05-30
• Status Verified: 2012-09
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Last Update Submitted: 2012-09-03
• Last Update Posted: 2012-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diabetes mellitus group	Magnetic Marker Imaging (MMI) with Magma 3D system	Subjects with Diabetes mellitus and symptoms of diabetic gastroparesis
Control group	Magnetic Marker Imaging (MMI) with Magma 3D system	Healthy volunteers as matched pairs according to gender and age

Primary Outcome Measures

Name	Time	Method
Frequency of gastric peristalsis	4 hours

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Universitätsklinikum Halle; 🇩🇪 Halle, Germany