Positron Emission Tomography (PET) Imaging of Pancreatic Beta-Cell Mass in Healthy and Type 1 Diabetic Patients
NCT00958997
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
1. Patients with Type 1 diabetes may be enrolled if they meet all of the following criteria:
- Have a diagnosis of Type 1 diabetes mellitus defined by ADA criteria or judgment of physician; diabetes onset younger than age 18, duration >5 years
- Have fasting C-Peptide ≤ 0.1 ng/ml
- BMI between 18 and 29 kg/m2
- Able to tolerate PET and MR imaging
- No metal implants
- No claustrophobia
2. Healthy volunteers may be enrolled if they meeting all of the following criteria:
- Have no history of Type 1 diabetes
- Fasting blood glucose ≤ 100 mg/dL
- Negative islet autoantibody testing
- BMI between 18 and 29 kg/m2
- Able to tolerate PET and MR imaging
- No history of previous allergic reactions to drugs
- No metal implants
- No claustrophobia
- Clinically significant renal dysfunction;
- Clinically significant liver dysfunction as determined by history, physical
examination, and standard liver function testing at screening (AST, ALT, Total/Direct
Bilirubin, Alkaline Phosphatase);
- Coagulopathy;
- History of allergic reactions to any drug
- Current use of any medications except for insulin for Type 1 diabetes
- Clinically significant cardiovascular disease or clinically significant abnormalities
on screening ECG (including but not limited to QTc>450 msec);
- Clinically significant psychiatric disease; Clinically significant pulmonary, renal or
hepatic impairment or cancer, have clinically significant infectious disease,
including AIDS or HIV infection, or previous positive test for hepatitis B, hepatitis
C, HIV-1, or HIV-2; subjects will be asked about this. No testing will be performed.
- Have a history of alcohol or substance abuse or dependence;
- Are women of childbearing potential not refraining from sexual activity or not using
adequate contraception. Women must not be pregnant (negative serum β-HCG at the time
of screen) or lactating at screening, and must agree to take appropriate steps not to
become pregnant during the study and for 30 days following the study.
- Currently receiving any investigational medications, or have participated in a trial
with investigational medications within the last 30 days.
- Have received a diagnostic or therapeutic radiopharmaceutical within 7 days prior to
participation in this study.
- Claustrophobia
- Metal implants (pace-maker, artificial joints, non-removable body piercings)
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Descriptive Information | |||||||||||||
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Brief Title | Positron Emission Tomography (PET) Imaging of Pancreatic Beta-Cell Mass in Healthy and Type 1 Diabetic Patients | ||||||||||||
Official Title | Quantitative PET Imaging of Pancreatic Beta-cell Mass in Healthy and Type 1 Diabetic Patients With 18F-FP-DTBZ (AV-133) | ||||||||||||
Brief Summary | Pancreatic Islet beta-cells are responsible for synthesizing and secreting appropriate amounts of insulin to regulate blood glucose levels. One factor in the development of diabetes is the loss of beta-cells. Developing treatments to prevent or restore islet beta-cell mass (BCM) in diabetic patients is hampered by a lack of methods for the non-invasive imaging of these cells. This study is designed to evaluate a radiolabeled compound that binds to the pancreatic islet. The investigators will test the ability of one promising imaging compound, 18F-9-fluoropropyl-(+)-dihydrotetrabenazine (18F-FP-DTBZ), to measure the amount of pancreatic islet beta-cells in patients with long-standing type-1 diabetes and in age-weight-matched healthy control subjects. | ||||||||||||
Detailed Description | Not Provided | ||||||||||||
Study Type | Observational | ||||||||||||
Study Design | Observational Model: Case-Control Time Perspective: Prospective | ||||||||||||
Target Follow-Up Duration | Not Provided | ||||||||||||
Biospecimen | Retention: Samples Without DNA Description: Blood plasma | ||||||||||||
Sampling Method | Non-Probability Sample | ||||||||||||
Study Population | Community Sample | ||||||||||||
Condition | Diabetes Mellitus, Type 1 | ||||||||||||
Intervention |
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Study Groups/Cohorts |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||||||||
Recruitment Information | |||||||||||||
Recruitment Status | Completed | ||||||||||||
Actual Enrollment | 16 | ||||||||||||
Original Estimated Enrollment | 20 | ||||||||||||
Actual Study Completion Date | May 2012 | ||||||||||||
Actual Primary Completion Date | October 2011 (Final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 55 Years (Adult) | ||||||||||||
Accepts Healthy Volunteers | Yes | ||||||||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
Listed Location Countries | United States | ||||||||||||
Removed Location Countries | |||||||||||||
Administrative Information | |||||||||||||
NCT Number | NCT00958997 | ||||||||||||
Other Study ID Numbers | Y-003-09 | ||||||||||||
Has Data Monitoring Committee | No | ||||||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||||||
IPD Sharing Statement | Not Provided | ||||||||||||
Responsible Party | Gary Cline, Yale University | ||||||||||||
Study Sponsor | Yale University | ||||||||||||
Collaborators |
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Investigators |
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PRS Account | Yale University | ||||||||||||
Verification Date | July 2012 |