NCT00280085

Brief Summary

Assess pancreatic beta cell function using MR imaging.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Dec 2005

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 20, 2006

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

August 7, 2009

Status Verified

September 1, 2008

First QC Date

January 18, 2006

Last Update Submit

August 6, 2009

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Pancreatic perfusion

Interventions

MR imagingPROCEDURE
Glucose clampPROCEDURE
ArginineDRUG
Also known as: R-Gene 10

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Normal Volunteers
  • T1DM and T2DM subjects

You may not qualify if:

  • Concomitant severe conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06510, United States

Location

Related Publications (1)

  • 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.

    PMID: 19488737DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Magnetic Resonance SpectroscopyGlucose Clamp TechniqueArginine

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesBlood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisAmino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, Essential

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 18, 2006

First Posted

January 20, 2006

Study Start

December 1, 2005

Study Completion

July 1, 2007

Last Updated

August 7, 2009

Record last verified: 2008-09

Locations

US(1)