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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. med. Thomas Seufferlein, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier:
NCT01607684
First received: May 20, 2012
Last updated: September 3, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Diabetic Polyneuropathy
Diabetic Gastroparesis
Diabetes Mellitus
Device: Magnetic Marker Imaging (MMI) with Magma 3D system
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Pilot Study to Evaluate Magnetic Marker Imaging on Diabetic Polyneuropathy and Gastroparesis

Resource links provided by NLM:


Further study details as provided by Martin-Luther-Universität Halle-Wittenberg:

Primary Outcome Measures:
  • Frequency of gastric peristalsis [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intensity of gastric peristaltic waves [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Influence of age on parameters of diabetic polyneuropathy measurable by magnetic marker imaging [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: January 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01607684

Locations
Germany
Universitätsklinikum Halle
Halle, Germany, 06120
Sponsors and Collaborators
Martin-Luther-Universität Halle-Wittenberg
Investigators
Principal Investigator: Thomas Seufferlein, MD Martin-Luther-Universität Halle-Wittenberg
  More Information

No publications provided

Responsible Party: Prof. Dr. med. Thomas Seufferlein, Prof. Dr. med., Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier: NCT01607684     History of Changes
Other Study ID Numbers: PAREMAG, CIV-11-05-000321
Study First Received: May 20, 2012
Last Updated: September 3, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Diabetes Mellitus
Gastroparesis
Polyneuropathies
Diabetic Neuropathies
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications

ClinicalTrials.gov processed this record on September 18, 2014