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

Last updated on November 21, 2019

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Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06510 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Normal Volunteers

- T1DM and T2DM subjects

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Concomitant severe conditions

NCT00280085
Pfizer
Terminated
The Aim is to Estimate the Total Amount of Insulin-producing Cells in the Pancreas by MRI.

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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 SummaryAssess pancreatic beta cell function using MR imaging.
Detailed DescriptionThe 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 DateNot 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 CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Yale University
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateSeptember 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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