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Type 1 DiabetesNCT02689479

11C-5-HTP PET in Clinical Islet Transplantation

A study testing Positron-Emission Tomography, 11C-5-HTP and Magnetic Resonance Imaging in people with Type 1 Diabetes, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in Sweden.

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

In people with type I diabetes, the insulin producing cells in the pancreas have been destroyed. Presently one can only evaluate the function of the graft through laboratory tests, blood sugars and the insulin requirements. The mass of the insulin producing cells and their location are not known. Read more about this study

Who is it for?
Any age
Conditions the study is for
Type 1 Diabetes
What is being tested?
Positron-Emission Tomography, 11C-5-HTP and Magnetic Resonance Imaging
How many people
8 participants
Where
2 sitesSweden
Study dates
May 2013to Sep 2014
Phase
Interventional
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Subjects must meet all of the following criteria to be considered eligible for participation in the study:
  • Subjects who are able to provide written informed consent and comply with the procedures of the study protocol.
  • Patient that has received an islet transplant in or outside the CIT01 trial (post primary endpoint).

Who cannot join

  • Subjects who meet any of these criteria are not eligible for participation in the study:
  • For female subjects: Positive serum pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures at the time of PET scan +/- 2 weeks.
  • Known history of severe co-existing cardiac disease, characterized by any one of the following conditions:
  • Recent myocardial infarction (within past 6 months).
  • Evidence of ischemia on functional cardiac exam within the last year.
  • Left ventricular ejection fraction <30%.
Show all 10Show fewer
  • Persistent elevation of liver function tests at the time of study entry. Persistent Aspartate Aminotransferase (serum glutamic-oxaloacetic transaminase), Alanine Aminotransferase (serum glutamate pyruvate transaminase), Alkaline phosphatase or total bilirubin, with values >1.5 times normal upper limits will exclude a patient.
  • Treatment with any anti-diabetic medication, other than insulin, within 4 weeks of enrollment.
  • Use of any investigational agents within 4 weeks of enrollment.
  • Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.

Trial locations and contacts

2 sites in 1 country.

Sweden2 sites

  • Karolinska University Hospital

    Stockholm

  • Uppsala University

    Uppsala

Other trials in Sweden

About this study

Official title: Evaluation of the Use of 11C-5-HTP PET to Calculate βCell Mass in Clinical Islet Transplantation (DAIT CIT-09)

In people with type I diabetes, the insulin producing cells in the pancreas have been destroyed. Presently one can only evaluate the function of the graft through laboratory tests, blood sugars and the insulin requirements. The mass of the insulin producing cells and their location are not known. The possibility to study the mass of insulin producing cells is of importance when developing new treatment regimes, in order to evaluate their efficacy on this parameter.

The researchers in this study are aiming to develop methods to measure the mass of insulin producing cells. A method (positron emission tomography, PET) previously used for the diagnosis of tumors of insulin producing cells may also be used to measure the amount of insulin producing cells in patients with type I diabetes. They plan to evaluate participants with type 1 diabetes that have undergone islet transplantation, to evaluate if PET can be used to measure the beta cell mass after islet transplantation.

Conditions
Type 1 Diabetes
Being tested
Positron-Emission Tomography, 11C-5-HTP, Magnetic Resonance Imaging, Mixed-Meal Tolerance Test (MMTT), Continuous Glucose Monitoring System® (CGMS)
Keywords
Clinical Islet Transplantation, Positron Emission Tomography (PET) Computed Tomography (CT) imaging
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

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

  • Positron-Emission TomographyProcedure or surgery

    Also called Positron Emission Tomography (PET) Imaging, PET Scan

    Dynamic scanning is performed for 60 minutes. Image acquisition is performed in 3D and reconstructed using an iterative OSEM VUEPOINT algorithm

  • 11C-5-HTPBiological

    150-400 MBq [11C]5-HTP (approximately 2-5 MBq/kg) is administered manually as an intravenous bolus in a intravenous catheter in the arm prior to PET imaging.

  • Magnetic Resonance ImagingProcedure or surgery

    Also called MRI Scans

    Analysis will focus on adipose tissue distribution and composition in the liver.

  • Mixed-Meal Tolerance Test (MMTT)Procedure or surgery

  • Continuous Glucose Monitoring System® (CGMS)Procedure or surgery

    CGMS involves the subcutaneous (SC) placement of a glucose sensor connected by tubing to a pager-sized monitoring device that stores glucose data. Subjects will have the sensor placed in the clinic and wear it continuously for 72 - 84 hours (Gold) or 72-144 hours (iPro2).

  • Glomerular Filtration Rate TestingProcedure or surgery

  • Blood drawProcedure or surgery

What is being measured

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

  1. The relationship between β cell mass calculated from the 11C-5-HTP PET scans and the MMTT C-peptide at 90 minutes

    Regression methods will be used to describe the association between the beta cell mass and 90 minute c-peptide.

    Measured: 8 month

Secondary outcomes (10)

  1. The relationship between βcell mass calculated from the 11C-5-HTP PET and the β-score computed at the time of the PET scan

    Regression methods will also be used to develop models to describe the relationship between the number of islets infused and the islet mass measured by PET.

    Measured: 8 month

  2. The relationship between βcell mass calculated from the 11C-5-HTP PET and CPGCR computed at the time of the PET scan

    Measured: 8 month

  3. The relationship between βcell mass calculated from the 11C-5-HTP PET and number of islets transplanted (Total IEQ)

    Measured: 8 month

  4. The distribution of islets in the liver

    Descriptive measures and scatterplots will be used to visualize the distribution of beta cells in selected regions of the liver.

    Measured: 8 month

  5. The distribution of fat accumulation in the liver

    Measured: 8 month

  6. The relationship between distribution patterns in the liver and MMTT C-peptide at 90 minutes computed at the time of the PET scan

    Measured: 8 month

  7. The relationship with PET and peak C-peptide

    Measured: 8 month

  8. The relationship with PET and C-peptide AUC

    Measured: 8 month

  9. The distribution of islets in the liver related to distribution of fat accumulation in the liver as measured by MRI

    Descriptive measures and scatterplots will be used to visualize the association between beta cells and fat deposits in the liver.

    Measured: 8 month

  10. The incidence and severity of adverse events related to the PET investigation including allergic reactions

    Measured: 8 month

Timeline

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

  1. First posted24 Feb 2016 (estimated)
  2. Study startMay 2013
  3. Primary completionSep 2014
  4. Study completionSep 2014

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02689479
Sponsor's protocol ID
DAIT CIT-09
Status last verified
Feb 2016
First submitted
22 Feb 2016
Last updated
24 Feb 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Eriksson O, Selvaraju R, Eich T, Willny M, Brismar TB, Carlbom L, Ahlstrom H, Tufvesson G, Lundgren T, Korsgren O. Positron Emission Tomography to Assess the Outcome of Intraportal Islet Transplantation. Diabetes. 2016 Sep;65(9):2482-9. doi: 10.2337/db16-0222. Epub 2016 Jun 20.

    PubMed 27325286

Questions about this trial

What is this clinical trial studying?

A study testing Positron-Emission Tomography, 11C-5-HTP and Magnetic Resonance Imaging in people with Type 1 Diabetes, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in Sweden.

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 3 inclusion and 10 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 24 Feb 2016. 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 Sweden. 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?

The relationship between β cell mass calculated from the 11C-5-HTP PET scans and the MMTT C-peptide at 90 minutes (time frame: 8 month). 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 NCT02689479, which also lists 1 linked publication.

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 24 Feb 2016.

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