NCT01607684

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 30, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

September 5, 2012

Status Verified

September 1, 2012

Enrollment Period

8 months

First QC Date

May 20, 2012

Last Update Submit

September 3, 2012

Conditions

Diabetic PolyneuropathyDiabetic GastroparesisDiabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Frequency of gastric peristalsis

    4 hours

Secondary Outcomes (3)

  • 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

Study Arms (2)

Diabetes mellitus group

OTHER

Subjects with Diabetes mellitus and symptoms of diabetic gastroparesis

Device: Magnetic Marker Imaging (MMI) with Magma 3D system

Control group

OTHER

Healthy volunteers as matched pairs according to gender and age

Device: Magnetic Marker Imaging (MMI) with Magma 3D system

Interventions

Magnetic Marker Imaging (MMI) with Magma 3D systemDEVICE

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 groupDiabetes mellitus group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Halle

Halle, 06120, Germany

Location

MeSH Terms

Conditions

Diabetic NeuropathiesDiabetes Mellitus

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Thomas Seufferlein, MD

    Martin-Luther-Universität Halle-Wittenberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

May 20, 2012

First Posted

May 30, 2012

Study Start

January 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

September 5, 2012

Record last verified: 2012-09

Locations

DE(1)