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Diabetes Mellitus, Type 1NCT00958997

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

An observational study of Diabetes Mellitus, Type 1, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
18F-FP-DTBZ (18F-AV-133) and Arginine-hydrochloride
Type of treatment
Injection or infusion
How many people
16 participants
Where
1 siteUnited States
Study dates
Aug 2009to May 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: Community Sample

Who may be able to join

  • 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
Show all 16Show fewer
  • No claustrophobia
  • 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

Who cannot join

  • 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);
Show all 13Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Yale University School of Medicine, PET Center

    New Haven, Connecticut, 06520

Other trials in United States

About this study

Official title: 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.

Being tested
18F-FP-DTBZ (18F-AV-133), Arginine-hydrochloride
Keywords
diabetes, islet, pancreas, beta cell mass, PET imaging, FPDTBZ, arginine stimulus test
Medical subject headings
Diabetes Mellitus, Type 1, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 18F-FP-DTBZ (18F-AV-133)Drug

    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).

  • Arginine-hydrochlorideBiological

    A bolus injection of 5g of 10% arginine-hydrochloride will be given over a period of 1 minute.

Study groups in NCT00958997
Study groupRoleWhat they receive
Type 1 diabetic subjectsPatients with Type 1 diabetes who have a diagnosis of Type 1 diabetes mellitus defined by ADA criteria or judgment of physician
Receives: Drug: 18F-FP-DTBZ (18F-AV-133); Biological: Arginine-hydrochloride
Healthy control subjectsAge-weight-BMI matched to the subjects with type-1 diabetes
Receives: Drug: 18F-FP-DTBZ (18F-AV-133); Biological: Arginine-hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PET-determined pancreatic islet beta-cell mass

    Measured: 150 minutes post-dose of imaging agent

Secondary outcomes (1)

  1. Insulin secretion response following an acute arginine-stimulus test

    Measured: Six minutes following administration of arginine challange

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2009 (estimated)
  2. Study startAug 2009
  3. Primary completionOct 2011
  4. Study completionMay 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00958997
Sponsor's protocol ID
Y-003-09
Status last verified
Jul 2012
First submitted
12 Aug 2009
Last updated
23 Jul 2012
Results posted
No
Data monitoring committee
No

Publications

  • Goswami R, Ponde DE, Kung MP, Hou C, Kilbourn MR, Kung HF. Fluoroalkyl derivatives of dihydrotetrabenazine as positron emission tomography imaging agents targeting vesicular monoamine transporters. Nucl Med Biol. 2006 Aug;33(6):685-94. doi: 10.1016/j.nucmedbio.2006.05.006.

    PubMed 16934687

  • Kilbourn MR, Hockley B, Lee L, Hou C, Goswami R, Ponde DE, Kung MP, Kung HF. Pharmacokinetics of [(18)F]fluoroalkyl derivatives of dihydrotetrabenazine in rat and monkey brain. Nucl Med Biol. 2007 Apr;34(3):233-7. doi: 10.1016/j.nucmedbio.2007.01.007.

    PubMed 17383572

  • Kung MP, Hou C, Goswami R, Ponde DE, Kilbourn MR, Kung HF. Characterization of optically resolved 9-fluoropropyl-dihydrotetrabenazine as a potential PET imaging agent targeting vesicular monoamine transporters. Nucl Med Biol. 2007 Apr;34(3):239-46. doi: 10.1016/j.nucmedbio.2006.12.005.

    PubMed 17383573

  • Kung MP, Hou C, Lieberman BP, Oya S, Ponde DE, Blankemeyer E, Skovronsky D, Kilbourn MR, Kung HF. In vivo imaging of beta-cell mass in rats using 18F-FP-(+)-DTBZ: a potential PET ligand for studying diabetes mellitus. J Nucl Med. 2008 Jul;49(7):1171-6. doi: 10.2967/jnumed.108.051680. Epub 2008 Jun 13.

    PubMed 18552132

  • Larsson H, Ahren B. Glucose-dependent arginine stimulation test for characterization of islet function: studies on reproducibility and priming effect of arginine. Diabetologia. 1998 Jul;41(7):772-7. doi: 10.1007/s001250050986.

    PubMed 9686917

  • Rickels MR, Naji A, Teff KL. Acute insulin responses to glucose and arginine as predictors of beta-cell secretory capacity in human islet transplantation. Transplantation. 2007 Nov 27;84(10):1357-60. doi: 10.1097/01.tp.0000287595.16442.a7.

    PubMed 18049122

  • Souza F, Simpson N, Raffo A, Saxena C, Maffei A, Hardy M, Kilbourn M, Goland R, Leibel R, Mann JJ, Van Heertum R, Harris PE. Longitudinal noninvasive PET-based beta cell mass estimates in a spontaneous diabetes rat model. J Clin Invest. 2006 Jun;116(6):1506-13. doi: 10.1172/JCI27645. Epub 2006 May 18.

    PubMed 16710474

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 1, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PET-determined pancreatic islet beta-cell mass (time frame: 150 minutes post-dose of imaging agent). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00958997, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2012.

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