Positron Emission Tomography (PET) Imaging of Pancreatic Beta-Cell Mass in Healthy and Type 1 Diabetic Patients

NCT00958997

Last updated date
Study Location
Yale University School of Medicine, PET Center
New Haven, Connecticut, 06520, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 1 Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Advanced Information
Descriptive Information
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
  • Drug: 18F-FP-DTBZ (18F-AV-133)
    The subjects will receive a single IV bolus of approximately 10 mCi 18F-AV-133.(Injection will contain no more than 25 µg of non-radiolabeled 19F-AV-133).
  • Biological: Arginine-hydrochloride
    A bolus injection of 5g of 10% arginine-hydrochloride will be given over a period of 1 minute.
Study Groups/Cohorts
  • Type 1 diabetic subjects
    Patients with Type 1 diabetes who have a diagnosis of Type 1 diabetes mellitus defined by ADA criteria or judgment of physician
    Interventions:
    • Drug: 18F-FP-DTBZ (18F-AV-133)
    • Biological: Arginine-hydrochloride
  • Healthy control subjects
    Age-weight-BMI matched to the subjects with type-1 diabetes
    Interventions:
    • Drug: 18F-FP-DTBZ (18F-AV-133)
    • Biological: Arginine-hydrochloride
Publications *

*   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
 (submitted: July 20, 2012)
16
Original Estimated Enrollment
 (submitted: August 13, 2009)
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:

  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

Exclusion Criteria:

  • 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 ?-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)
Sex/Gender
Sexes Eligible for Study:All
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
  • Pfizer
  • Avid Radiopharmaceuticals
Investigators
Principal Investigator:Gary W Cline, Ph.D.Yale School of Medicine
Study Director:Yu-Shin Ding, Ph.D.Yale School of Medicine
Study Director:Kitt F Petersen, M.D.Yale School of Medicine
Study Director:Richard Carson, Ph.D.Yale School of Medicine
PRS Account Yale University
Verification Date July 2012