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The Aim is to Estimate the Total Amount of Insulin-producing Cells in the Pancreas by MRI.

This study has been terminated.
(Explanation provided in detailed descriptiong section of record.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00280085
First Posted: January 20, 2006
Last Update Posted: August 7, 2009
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.
Collaborator:
Yale University
Information provided by:
Pfizer
  Purpose
Assess pancreatic beta cell function using MR imaging.

Condition Intervention
Diabetes Mellitus Procedure: MR imaging Procedure: Glucose clamp Drug: Arginine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pancreatic Beta-Cell Mass And Function Quantification By Means Of Perfusion Imaging

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Pancreatic perfusion

Enrollment: 29
Study Start Date: December 2005
Study Completion Date: July 2007
Intervention Details:
    Procedure: MR imaging Procedure: Glucose clamp Drug: Arginine
    Other Name: R-Gene 10
Detailed Description:
The study was terminated on July 31st, 2007. The study was discontinued, as we have not met the primary end point, differentiation between normal volunteers and subjects with type 1 diabetes mellitus. There were no safety concerns.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Normal Volunteers
  • T1DM and T2DM subjects

Exclusion Criteria:

  • Concomitant severe conditions
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00280085


Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Pfizer
Yale University
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00280085     History of Changes
Other Study ID Numbers: A9001280
First Submitted: January 18, 2006
First Posted: January 20, 2006
Last Update Posted: August 7, 2009
Last Verified: September 2008

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases