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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01607684
Recruitment Status : Completed
First Posted : May 30, 2012
Last Update Posted : September 5, 2012
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. med. Thomas Seufferlein, Martin-Luther-Universität Halle-Wittenberg

Tracking Information
First Submitted Date  ICMJE May 20, 2012
First Posted Date  ICMJE May 30, 2012
Last Update Posted Date September 5, 2012
Study Start Date  ICMJE January 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2012)
Frequency of gastric peristalsis [ Time Frame: 4 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2012)
  • Intensity of gastric peristaltic waves [ Time Frame: 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) [ Time Frame: 4 hours ]
  • Influence of age on parameters of diabetic polyneuropathy measurable by magnetic marker imaging [ Time Frame: 4 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Study to Evaluate Magnetic Marker Imaging on Diabetic Polyneuropathy and Gastroparesis
Official Title  ICMJE Pilot Study to Evaluate Magnetic Marker Imaging on Diabetic Polyneuropathy and Gastroparesis
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Diabetic Polyneuropathy
  • Diabetic Gastroparesis
  • Diabetes Mellitus
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Diabetes mellitus group
    Subjects with Diabetes mellitus and symptoms of diabetic gastroparesis
    Intervention: Device: Magnetic Marker Imaging (MMI) with Magma 3D system
  • Control group
    Healthy volunteers as matched pairs according to gender and age
    Intervention: Device: Magnetic Marker Imaging (MMI) with Magma 3D system
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 24, 2012)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01607684
Other Study ID Numbers  ICMJE PAREMAG
CIV-11-05-000321 ( Other Identifier: European Databank on Medical Devices - EUDAMED )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Dr. med. Thomas Seufferlein, Martin-Luther-Universität Halle-Wittenberg
Study Sponsor  ICMJE Martin-Luther-Universität Halle-Wittenberg
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thomas Seufferlein, MD Martin-Luther-Universität Halle-Wittenberg
PRS Account Martin-Luther-Universität Halle-Wittenberg
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP