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Trial record 1 of 1 for:    NCT00280085
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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

Tracking Information
First Submitted Date  ICMJE January 18, 2006
First Posted Date  ICMJE January 20, 2006
Last Update Posted Date August 7, 2009
Study Start Date  ICMJE December 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2006)
Pancreatic perfusion
Original Primary Outcome Measures  ICMJE
 (submitted: January 18, 2006)
Pancreatic perfusion Information omitted due to commercial sensitivity
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Aim is to Estimate the Total Amount of Insulin-producing Cells in the Pancreas by MRI.
Official Title  ICMJE Pancreatic Beta-Cell Mass And Function Quantification By Means Of Perfusion Imaging
Brief Summary Assess pancreatic beta cell function using MR imaging.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Diabetes Mellitus
Intervention  ICMJE
  • Procedure: MR imaging
  • Procedure: Glucose clamp
  • Drug: Arginine
    Other Name: R-Gene 10
Study Arms  ICMJE Not Provided
Publications * Hirshberg B, Qiu M, Cali AM, Sherwin R, Constable T, Calle RA, Tal MG. Pancreatic perfusion of healthy individuals and type 1 diabetic patients as assessed by magnetic resonance perfusion imaging. Diabetologia. 2009 Aug;52(8):1561-5. doi: 10.1007/s00125-009-1406-8. Epub 2009 Jun 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 5, 2009)
29
Original Enrollment  ICMJE
 (submitted: January 18, 2006)
80
Actual Study Completion Date  ICMJE July 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Normal Volunteers
  • T1DM and T2DM subjects

Exclusion Criteria:

  • Concomitant severe conditions
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00280085
Other Study ID Numbers  ICMJE A9001280
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Yale University
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP