NCT02689479

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2013

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 24, 2016

Completed
Last Updated

February 24, 2016

Status Verified

February 1, 2016

Enrollment Period

1.3 years

First QC Date

February 22, 2016

Last Update Submit

February 22, 2016

Conditions

Type 1 Diabetes

Keywords

Clinical Islet TransplantationPositron Emission Tomography (PET) Computed Tomography (CT) imaging

Outcome Measures

Primary Outcomes (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.

    8 month

Secondary Outcomes (10)

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

    8 month

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

    8 month

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

    8 month

  • The distribution of islets in the liver

    8 month

  • The distribution of fat accumulation in the liver

    8 month

  • +5 more secondary outcomes

Interventions

Positron-Emission TomographyPROCEDURE

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

Also known as: Positron Emission Tomography (PET) Imaging, PET Scan
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

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

Also known as: MRI Scans
Mixed-Meal Tolerance Test (MMTT)PROCEDURE
Continuous Glucose Monitoring System® (CGMS)PROCEDURE

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
Blood drawPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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%.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Karolinska University Hospital

Stockholm, Sweden

Location

Uppsala University

Uppsala, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 27325286DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Magnetic Resonance SpectroscopyContinuous Glucose MonitoringBlood Specimen Collection

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesBlood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicSpecimen HandlingPuncturesSurgical Procedures, Operative

Study Officials

  • Olle Korsgren

    Uppsala University Hospital

    PRINCIPAL INVESTIGATOR

  • Torbjorn Lundgren, MD

    Karolinska University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2016

First Posted

February 24, 2016

Study Start

May 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

February 24, 2016

Record last verified: 2016-02

Locations

SE(2)