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

July 20, 2012 updated by: Gary Cline, Yale University

Quantitative PET Imaging of Pancreatic Beta-cell Mass in Healthy and Type 1 Diabetic Patients With 18F-FP-DTBZ (AV-133)

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.

Study Overview

Study Type

Observational

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University School of Medicine, PET Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Community Sample

Description

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 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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).
A bolus injection of 5g of 10% arginine-hydrochloride will be given over a period of 1 minute.
Healthy control subjects
Age-weight-BMI matched to the subjects with type-1 diabetes
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).
A bolus injection of 5g of 10% arginine-hydrochloride will be given over a period of 1 minute.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PET-determined pancreatic islet beta-cell mass
Time Frame: 150 minutes post-dose of imaging agent
150 minutes post-dose of imaging agent

Secondary Outcome Measures

Outcome Measure
Time Frame
Insulin secretion response following an acute arginine-stimulus test
Time Frame: Six minutes following administration of arginine challange
Six minutes following administration of arginine challange

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

August 12, 2009

First Submitted That Met QC Criteria

August 13, 2009

First Posted (Estimate)

August 14, 2009

Study Record Updates

Last Update Posted (Estimate)

July 23, 2012

Last Update Submitted That Met QC Criteria

July 20, 2012

Last Verified

July 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 1

Clinical Trials on 18F-FP-DTBZ (18F-AV-133)

3
Subscribe