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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 August 25, 2014