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

January 18, 2006
August 6, 2009
December 2005
Not Provided
Pancreatic perfusion
Pancreatic perfusion Information omitted due to commercial sensitivity
Complete list of historical versions of study NCT00280085 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Aim is to Estimate the Total Amount of Insulin-producing Cells in the Pancreas by MRI.
Pancreatic Beta-Cell Mass And Function Quantification By Means Of Perfusion Imaging

Assess pancreatic beta cell function using MR imaging.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Diabetes Mellitus
  • Procedure: MR imaging
  • Procedure: Glucose clamp
  • Drug: Arginine
    Other Name: R-Gene 10
Not Provided
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. Epub 2009 Jun 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
29
July 2007
Not Provided

Inclusion Criteria:

  • Normal Volunteers
  • T1DM and T2DM subjects

Exclusion Criteria:

  • Concomitant severe conditions
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00280085
A9001280
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Yale University
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2008

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