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Completed

NCT Number: NCT01607684

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

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.

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Key information

Conditions

Diabetic Polyneuropathy Diabetes Complications Diabetes Mellitus Diabetic Gastroparesis Diabetic Neuropathies Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nervous System Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Peripheral Nervous System Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Universitätsklinikum Halle

Halle, 06120, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic Marker Imaging (MMI) with Magma 3D system

Device

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 outcomes

  1. Frequency of gastric peristalsis

    Time frame: 4 hours

Secondary outcomes

  1. Intensity of gastric peristaltic waves

    Time frame: 4 hours

  2. 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

  3. Influence of age on parameters of diabetic polyneuropathy measurable by magnetic marker imaging

    Time frame: 4 hours

Sponsors and collaborators

Lead sponsor

Martin-Luther-Universität Halle-Wittenberg

Other

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 30, 2012
Registry last updated
Sep 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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