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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:
Collaborator:
Yale University
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00280085
First received: January 18, 2006
Last updated: August 6, 2009
Last verified: September 2008
History of Changes
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pancreatic Beta-Cell Mass And Function Quantification By Means Of Perfusion Imaging

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Normal Volunteers
  • T1DM and T2DM subjects

Exclusion Criteria:

  • Concomitant severe conditions
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided by Pfizer

Additional 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
Study First Received: January 18, 2006
Last Updated: August 6, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 19, 2013