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

Pancreatic perfusion

Original Primary Outcome Measures ^ICMJE

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

Original Enrollment ^ICMJE

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

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