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

Phase 2

Completed

• Conditions: Diabetic Polyneuropathy; Diabetic Gastroparesis; Diabetes Mellitus

• 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)

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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