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Biomagnetic Characterization of Gastric Dysrhythmias:Study 2 (SQUID)

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Alan Bradshaw, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:
NCT00178984
First received: September 13, 2005
Last updated: April 5, 2017
Last verified: April 2017
  Purpose
The purpose of this study is to use the Squid magnetometer (Superconducting QUantum Interference Device) to help diagnose electrical and mechanical abnormalities of the stomach and intestines.

Condition
Ischemia

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Biomagnetic Characterization of Gastric Dysrhythmias:Study 2

Resource links provided by NLM:


Further study details as provided by Vanderbilt University Medical Center:

Primary Outcome Measures:
  • to observe a difference in the magnetic activity between the normal and diseased smooth muscle of the stomach and intestines. [ Time Frame: 2010 ]

Secondary Outcome Measures:
  • to specifically study the electrical activity of diabetics with an abnormal gastric emptying. [ Time Frame: 2010 ]
  • Measurement of mesenteric ischemia [ Time Frame: 2010 ]

Enrollment: 78
Study Start Date: June 2000
Study Completion Date: August 10, 2012
Primary Completion Date: August 10, 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
poor blood flow
Group with partial ischemia to the small intestine
Good blood flow
Group with normal blood flow, given different conditions to effect electrical currents in normal smooth muscle

Detailed Description:
The Squid magnetometer is a non-invasive investigational device that measures the electrical activity in the smooth muscle of the intestines. Volunteers with normal bowel activity, those with gastric problems, and diabetics with gastric problems will be studied under the SQuid to determine normal and abnormal activity. Diabetics with an abnormal gastric emptying study will be asked to participate.
  Eligibility

Ages Eligible for Study:   14 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Primary Care clinic
Criteria

Inclusion Criteria:

  • Normal volunteers, those with stomach problems, and Diabetics with abnormal gastric emptying study

Exclusion Criteria:

  • Diabetics with a normal gastric emptying study
  • Participants with claustrophobia
  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: NCT00178984

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Leonard A. Bradshaw, Ph.D. Vanderbilt University Department of Physics and Surgery
  More Information

Responsible Party: Alan Bradshaw, Research Assistant Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00178984     History of Changes
Other Study ID Numbers: 051175
5R01DK058697 ( US NIH Grant/Contract Award Number )
Study First Received: September 13, 2005
Last Updated: April 5, 2017

Keywords provided by Vanderbilt University Medical Center:
Blood supply
Mesentery

Additional relevant MeSH terms:
Ischemia
Arrhythmias, Cardiac
Pathologic Processes
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 28, 2017