Eligibility criteria
Condition
Diabetes Mellitus
Sex
Females and Males
Age
18-65 years
Inclusion criteria
Show details
- Normal Volunteers
- T1DM and T2DM subjects
Exclusion criteria
Show details
- Concomitant severe conditions
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The Aim is to Estimate the Total Amount of Insulin-producing Cells in the Pancreas by MRI.
NCT00280085
Last updated on November 21, 2019
About this Study
Assess pancreatic beta cell function using MR imaging.
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 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 | ||||
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
BY PHONE
Pfizer Clinical Trials Contact Center
1-800-718-1021