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NCT Number: NCT02689479

11C-5-HTP PET in Clinical Islet Transplantation

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska University Hospital, Stockholm, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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).

Exclusion criteria

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.

Treatment and study plan

Positron-Emission Tomography

Procedure

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

Other names: Positron Emission Tomography (PET) Imaging, PET Scan

11C-5-HTP

Biological

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 Imaging

Procedure

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

Other names: 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 Testing

Procedure

Blood draw

Procedure

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

    Time frame: 8 month

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

Secondary outcomes

  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

    Time frame: 8 month

    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.

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

    Time frame: 8 month

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

    Time frame: 8 month

  4. The distribution of islets in the liver

    Time frame: 8 month

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

  5. The distribution of fat accumulation in the liver

    Time frame: 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

    Time frame: 8 month

  7. The relationship with PET and peak C-peptide

    Time frame: 8 month

  8. The relationship with PET and C-peptide AUC

    Time frame: 8 month

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

    Time frame: 8 month

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

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

    Time frame: 8 month

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 24, 2016
Registry last updated
Feb 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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