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

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ClinicalTrials.gov Identifier: NCT00280085
Recruitment Status : Terminated (Explanation provided in detailed descriptiong section of record.)
First Posted : January 20, 2006
Last Update Posted : August 7, 2009
Sponsor:
Collaborator:
Yale University
Information provided by:
Pfizer

Brief Summary:
Assess pancreatic beta cell function using MR imaging.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Procedure: MR imaging Procedure: Glucose clamp Drug: Arginine Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
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
Study Start Date : December 2005
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Procedure: MR imaging Procedure: Glucose clamp Drug: Arginine
    Other Name: R-Gene 10


Primary Outcome Measures :
  1. Pancreatic perfusion


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

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

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 Posted: January 20, 2006    Key Record Dates
Last Update Posted: August 7, 2009
Last Verified: September 2008

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