An interventional study of Positron-Emission Tomography and 11C-5-HTP in Type 1 Diabetes, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 2 sites in Sweden. Per ClinicalTrials.gov, last updated 2016-02-24.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Not applicable, Interventional, and Diagnostic
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.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's enrollment of 8 is below the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.
Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects must meet all of the following criteria to be considered eligible for participation in the study:
Exclusion Criteria:
Subjects who meet any of these criteria are not eligible for participation in the study:
Known history of severe co-existing cardiac disease, characterized by any one of the following conditions:
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
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.
Analysis will focus on adipose tissue distribution and composition in the liver.
Also known as: MRI Scans
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).
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.
Time frame: 8 month
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.
Time frame: 8 month
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
The relationship between βcell mass calculated from the 11C-5-HTP PET and number of islets transplanted (Total IEQ)
Time frame: 8 month
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.
Time frame: 8 month
The distribution of fat accumulation in the liver
Time frame: 8 month
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
The relationship with PET and peak C-peptide
Time frame: 8 month
The relationship with PET and C-peptide AUC
Time frame: 8 month
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.
Time frame: 8 month
The incidence and severity of adverse events related to the PET investigation including allergic reactions
Time frame: 8 month
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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National Institute of Allergy and Infectious Diseases (NIAID)