An observational study in Type 1 Diabetes Mellitus, sponsored by Radboud University Medical Center. Terminated at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-14.
Sponsored by Radboud University Medical Center · Observational
The primary aim of this study is to measure (residual) beta cell mass in type 1 diabetes (T1D) patients with stable near-normal and unstable glucose control using PET/CT imaging, to improve the understanding of the relation between beta cell mass and glycemic control in T1D.
Type 1 diabetes (T1D) is characterized by a progressive decrease in beta cell function due to an autoimmune attack on the beta cells, which will lead to a reduction in insulin secretion. Endogenous insulin secretion can be determined measuring C-peptide, which is secreted in equal amounts to insulin. The loss of insulin secretion, indicated by an immeasurable C-peptide level, will hamper glycemic control which results in increased glycated haemoglobin (HbA1c) levels. Also, hypoglycemic events can occur more frequently. Initially, the belief was that this could be explained by the loss of all pancreatic beta cells due to the autoimmune attack. However, recent literature suggests that a considerable number of beta cells can survive this attack. This could mean that certain beta cells survived, but have lost their function. The ratio of functional and non-functional residual beta cells might play an important role in the degree of glycemic control. It would therefore be of great interest to study residual beta cell mass in two types of T1D patients that differ in glycemic control. Although both types of patients receive treatment, one group of patients is characterized by a stable near-normal glucose control while the second group is characterized by an unstable glucose control. In case glycemic control mostly depends on beta cell function and less on beta cell mass, novel therapies could focus on the functional reactivation of these non-functional beta cells to restore overall beta cell function. This could especially be in favour of patients with an unstable glucose control. Beta cell mass will be determined using Ga-68-NODAGA-exendin-4 positron emission tomography (PET), which allows visualization of pancreatic beta cells as well as absolute quantification of tracer uptake, providing a measure for the pancreatic beta cell mass. The outcome of this study will lead to a better understanding of the relation between the amount of residual beta cells, beta cell function and the influence of glycemic control. This could provide new insights regarding the development of new therapies to improve beta cell function and glycemic control, which could lower disease burden and improve the patient's quality of life.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's enrollment of 16 is below the median of 120 across 748 observational studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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The study population will include 18 individuals with T1D for at least 1 year with a minimum age of 18 years. This population consists of two groups that include 9 subjects with stable near-normal glucose control and 9 individuals with unstable glucose control. The differentiation between T1D patients with stable near-normal and unstable glucose control will be based on their HbA1c value, the number of severe hypoglycemic events and the patient's hypoglycaemic awareness.
Group 1 (stable glycemic control)
Group 2 (unstable glycemic control) Age ≥18 years
Exclusion Criteria:
* Mixed-meal tolerance test * Intravenous injection with gallium-68-exendin followed by a PET/CT scan
Radiation: gallium-68-exendin PET/CT
* Mixed-meal tolerance test * Intravenous injection with gallium-68-exendin followed by a PET/CT scan
Radiation: gallium-68-exendin PET/CT
PET/CT scan after injection with gallium-68-exendin
Beta cell mass
Pancreatic uptake of the tracer is measured by quantitative analysis (measure for beta cell mass)
Time frame: 2 years
Beta cell mass vs. beta cell function
The correlation of the measured beta cell mass to the beta cell function
Time frame: 2 years
This study is terminated, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Radboud University Medical Center