The Aim is to Estimate the Total Amount of Insulin-producing Cells in the Pancreas by MRI.
NCT00280085
Last updated date
ABOUT THIS STUDY
Assess pancreatic beta cell function using MR imaging.
Study Location
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Eligibility Criteria
condition
Diabetes Mellitus
Sex
Females and Males
Age
18-65 years
Inclusion Criteria
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- Normal Volunteers
- T1DM and T2DM subjects
Exclusion Criteria
Show details
- Concomitant severe conditions
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Advanced Information
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 |
| |||
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 | 29 | |||
Original Enrollment ICMJE | 80 | |||
Actual Study Completion Date ICMJE | July 2007 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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 |
| |||
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 |