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Type 1 DiabetesNCT00771576

PET Scan Imaging of Beta Cell Mass

An observational study of Type 1 Diabetes and Obesity, run by Columbia University at 2 sites 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

The investigators hypothesize that PET scans will be able to differentiate between normal, reduced or increased BCM in human subjects. Subjects with normal BCM will be recruited from among normal weight nondiabetic people with plasma insulin levels within the normal range. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Type 1 Diabetes, Obesity
How many people
30 participants
Where
2 sitesUnited States
Study dates
Sep 2006to 13 Jun 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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: Potential subjects with diabetes will be recruited from among the patients cared for at the Naomi Berrie Diabetes Center. Nondiabetic subjects will either be referred by their physicians or by word of mouth. Primary care physicians will be made aware of the study by fliers.

Who may be able to join

  • Potential participants must meet all of the following inclusion criteria:
  • Informed consent obtained from participants
  • Age 18-45 years
  • Healthy non-diabetic subjects will have normal fasting blood sugar (<100 mg/dl), body mass index (BMI) 18.5-24.9, no history of type 2 diabetes in first degree relative
  • Type 1 diabetes defined by: American Diabetes Association (ADA) criteria or judgment of physician; diabetes onset younger than age 18, duration >5 - years, BMI 18.5-24.9. Insulin dose <0.8 units/kg/day. Fasting c-peptide < 0.1 ng/ml
  • Obese hyper-insulinemic subjects will have BMI > 30 and fasting insulin>20 and c-peptide> 4.6 ng/ml and normal fasting blood sugar <100 mg/dl.
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  • Able to tolerate PET imaging: not claustrophobic, able to lie supine for 1.5 hours
  • Normal liver and renal function tests including normal spot urine microalbumin /creatinine; normal CBC including hematocrit >31.8% in women, >36.7% in men, white blood cell (WBC) count >3.4 K/mm3 and platelet count >162 K/mm3
  • Adequate collateral circulation in the wrist as assessed by Allen Test.

Who cannot join

  • Potential participants must not have any of the following exclusion criteria:
  • Previous or current treatment with drugs influencing beta cell function or insulin sensitivity (e.g. oral hypoglycemic agents, glucocorticoids); or with antipsychotic, antianxiety, or antidepressant medications (eg monoamine oxidase (MAO) inhibitors, 5-hydroxytryptamine (5-HT) inhibitors, tricyclic antidepressants); or treatment with reserpine; or treatment with beta2receptor agonists (eg, terbutaline); or treatment with anticoagulant medication.
  • History of movement disorder such as Parkinson's Disease or Huntington's Disease
  • History of or psychiatric illness such as depression, bipolar disease, anxiety or schizophrenia.
  • If a female of childbearing age, currently pregnant, breastfeeding or not using a form of birth control
  • Previous or current use of cocaine, methamphetamine, ecstasy
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  • Current daily intake of caffeine >500 mg/day (>45 cups of coffee; >10 12oz cans of soda)
  • Current history of cigarette smoking
  • Consumption of more than 1 alcoholic drink per day
  • Evidence of chronic infection
  • History of malignancy
  • Any prior participation in other research protocols within the past year that involve radiation, with the exception of plain radiography studies (i.e., chest xrays).
  • Medical implant

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Naomi Berrie Diabetes Cener

    New York, New York, 10032

  • Kreitchman PET Center Columbia University Medical Center

    New York, New York, 19932

Other trials in United States

About this study

Official title: PET Scan Imaging of Pancreatic Beta Cell Mass With DTBZ

The investigators hypothesize that PET scans will be able to differentiate between normal, reduced or increased BCM in human subjects. Subjects with normal BCM will be recruited from among normal weight nondiabetic people with plasma insulin levels within the normal range. Subjects with predicted reduced BCM will be recruited from among patients with T1DM who have with low or not measurable insulin levels. If results from the nondiabetic subjects and the subjects with T1DM are found to differ significantly, subjects with increased BCM will be recruited from among patients with hyperinsulinemia including those with obesity and the metabolic syndrome. PET scan measurements of the pancreas will be obtained and compared in people predicted, on the basis of biochemical testing, to have normal or reduced, or increased BCM.

Read the detailed description

An important determinant of progression to diabetes is beta cell mass (BCM). Measurement of plasma insulin has been used as a surrogate marker but insulin levels often do not correlate well with beta cell mass and development of means to assess BCM would provide an important endpoint. For example, high-risk individuals could be monitored prior to onset of diabetes or patients could be monitored prospectively to determine the progression of their disease and response to therapy.

Both Type 1 diabetes mellitus (T1DM) and Type 2 diabetes mellitus (T2DM) develop when there is impaired insulin production. The amount of insulin that can be produced, the amount of insulin producing beta cells in the pancreas and level of insulin and glucose in the blood are, however, imperfectly correlated. The development of a reliable method to noninvasively quantitate the beta cell mass (BCM) would be of great benefit by providing an important endpoint for the development of new treatments of T1DM and T2DM. The investigators have previously identified a specific marker on islet cells called vesicular monoamine transporter 2 (VMAT2) that they now propose to use in positron emission tomography (PET) scanning to determine islet cell mass. This radioligand, [11C] Dihydrotetrabenazine (DTBZ), has been used previously in human subjects in clinical trials evaluating PET scanning of the brain in patients with bipolar illness and schizophrenia compared to healthy control subjects.

Keywords
Diabetes Mellitus, T1DM
Medical subject headings
Diabetes Mellitus, Type 1, Obesity, Diabetes Mellitus

What participants receive

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

Study groups in NCT00771576
Study groupRoleWhat they receive
A. Healthy Controlssubjects w/ predicted normal BCM (healthy, normalweight, nondiabetic individuals who have stimulated insulin and cpeptide levels within the normal range);
B. Longstanding T1Dsubjects with predicted reduced beta cell mass (subjects with established T1DM who have low or not measurable stimulated insulin and c peptide levels);
C. Obese Subjectssubjects with predicted increased beta cell mass (euglycemic obese subjects with fasting hyperinsulinemia).

What is being measured

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

  1. Pancreas [11C] DTBZ binding

    Measured: Once

Timeline

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

  1. First posted13 Oct 2008 (estimated)
  2. Study startSep 2006
  3. Primary completionSep 2008
  4. Study completion13 Jun 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
Other
Time perspective
Retrospective
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00771576
Sponsor's protocol ID
AAAB0002
Status last verified
Jul 2017
First submitted
10 Oct 2008
Last updated
18 Jul 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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

  • Simpson NR, Souza F, Witkowski P, Maffei A, Raffo A, Herron A, Kilbourn M, Jurewicz A, Herold K, Liu E, Hardy MA, Van Heertum R, Harris PE. Visualizing pancreatic beta-cell mass with [11C]DTBZ. Nucl Med Biol. 2006 Oct;33(7):855-64. doi: 10.1016/j.nucmedbio.2006.07.002.

    PubMed 17045165

  • Murthy R, Harris P, Simpson N, Van Heertum R, Leibel R, Mann JJ, Parsey R. Whole body [11C]-dihydrotetrabenazine imaging of baboons: biodistribution and human radiation dosimetry estimates. Eur J Nucl Med Mol Imaging. 2008 Apr;35(4):790-7. doi: 10.1007/s00259-007-0648-2. Epub 2007 Dec 4.

    PubMed 18060547

Questions about this trial

What is this clinical trial studying?

An observational study of Type 1 Diabetes and Obesity, run by Columbia University at 2 sites 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 9 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 18 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Pancreas [11C] DTBZ binding (time frame: Once). 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 NCT00771576, which also lists 3 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 18 Jul 2017.

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