Back to resultsPilot Study to Evaluate Magnetic Marker Imaging on Diabetic Polyneuropathy and Gastroparesis
Primary Purpose
Diabetic Polyneuropathy, Diabetic Gastroparesis, Diabetes Mellitus
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Magnetic Marker Imaging (MMI) with Magma 3D system
Sponsored by
About this trial
This is an interventional diagnostic trial for Diabetic Polyneuropathy
Eligibility Criteria
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
Sites / Locations
- Universitätsklinikum Halle
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Diabetes mellitus group
Control group
Arm Description
Subjects with Diabetes mellitus and symptoms of diabetic gastroparesis
Healthy volunteers as matched pairs according to gender and age
Outcomes
Primary Outcome Measures
Frequency of gastric peristalsis
Secondary Outcome Measures
Intensity of gastric peristaltic waves
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)
Influence of age on parameters of diabetic polyneuropathy measurable by magnetic marker imaging
Full Information
NCT ID
NCT01607684
First Posted
May 20, 2012
Last Updated
September 3, 2012
Sponsor
Martin-Luther-Universität Halle-Wittenberg
1. Study Identification
Unique Protocol Identification Number
NCT01607684
Brief Title
Pilot Study to Evaluate Magnetic Marker Imaging on Diabetic Polyneuropathy and Gastroparesis
Official Title
Pilot Study to Evaluate Magnetic Marker Imaging on Diabetic Polyneuropathy and Gastroparesis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Martin-Luther-Universität Halle-Wittenberg
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Polyneuropathy, Diabetic Gastroparesis, Diabetes Mellitus
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diabetes mellitus group
Arm Type
Other
Arm Description
Subjects with Diabetes mellitus and symptoms of diabetic gastroparesis
Arm Title
Control group
Arm Type
Other
Arm Description
Healthy volunteers as matched pairs according to gender and age
Intervention Type
Device
Intervention Name(s)
Magnetic Marker Imaging (MMI) with Magma 3D system
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frequency of gastric peristalsis
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Intensity of gastric peristaltic waves
Time Frame
4 hours
Title
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)
Time Frame
4 hours
Title
Influence of age on parameters of diabetic polyneuropathy measurable by magnetic marker imaging
Time Frame
4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Seufferlein, MD
Organizational Affiliation
Martin-Luther-Universität Halle-Wittenberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum Halle
City
Halle
ZIP/Postal Code
06120
Country
Germany
12. IPD Sharing Statement
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Pilot Study to Evaluate Magnetic Marker Imaging on Diabetic Polyneuropathy and Gastroparesis
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