The Aim is to Estimate the Total Amount of Insulin-produc... | NCT00280085

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

NCT00280085

Sponsor

Pfizer

Status

Terminated

Last Update Posted

Aug 7, 2009Estimated

Enrollment

29Actual

Phase

Not Applicable

Conditions

Diabetes Mellitus

Interventions

MR imaging
Glucose clamp
Arginine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2008

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Explanation provided in detailed descriptiong section of record.

Expanded Access Info

Start Date

Dec 2005

Primary Completion Date

Not provided

Completion Date

Jul 2007Actual

First Submitted Date

Jan 18, 2006

First Submission Date that Met QC Criteria

Jan 18, 2006

First Posted Date

Jan 20, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 6, 2009

Last Update Posted Date

Aug 7, 2009Estimated

Name	Class
Yale University	OTHER

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

29Actual

Measure	Description	Time Frame
Pancreatic perfusion

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Normal Volunteers
T1DM and T2DM subjects

Exclusion Criteria:

Concomitant severe conditions

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		New Haven	Connecticut	06510	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19488737	Derived	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.

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D009682	Magnetic Resonance Spectroscopy
D015309	Glucose Clamp Technique
D001120	Arginine

ID	Term
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques
D001774	Blood Chemical Analysis

Name	Type	Other Names
MR imaging	Procedure
Glucose clamp	Procedure
Arginine	Drug	R-Gene 10