Beta Cell Imaging in T1D Patients With a Different Glycemic Control

Type 1 Diabetes Mellitus Clinical Trial

— GLP1-reg  

Official title:

Beta Cell Imaging in Type 1 Diabetes With Stable Near-normal and Unstable Glucose Control Using PET

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03785275
• Other study ID #: NL59582.091.17
• Status: Terminated
• Start date: December 6, 2017
• Est. completion date: November 9, 2020

Study information

• Verified date: January 2022
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: November 9, 2020
• Est. primary completion date: November 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Group 1 (stable glycemic control)

• Age =18 years

• T1D diagnosed =1 year at the start of the study

• HbA1c <7 (<53 mmol/mol)

• 17= BMI =30 kg/m2

• No severe hypoglycemic events in the past year and a maximum of 2 severe hypoglycemic events in their entire life.

• Intact hypoglycemic awareness

• Ability to sign informed consent

Group 2 (unstable glycemic control) Age =18 years

• T1D diagnosed =1 year at the start of the study

• HbA1c >8.5 (>69 mmol/mol)

• 17= BMI =30 kg/m2

• Minimum of 2 severe hypoglycemic events in the past year, or an impaired awareness of hypoglycemia (subjects may comply with both criteria, but this is not a requirement)

• Ability to sign informed consent

Exclusion Criteria:

• Previous treatment (within 6 months) with synthetic Exendin (Exenatide, Byetta®) or Dipeptidyl-Peptidase IV inhibitors

• Liver disease

• Renal disease

• Pregnancy or the wish to become pregnant within 6 months after the study

• Breastfeeding

• BMI <17 kg/m2 or BMI >30 kg/m2

• Age <18 years

• Inability to sign informed consent

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Radiation:
• gallium-68-exendin PET/CT
PET/CT scan after injection with gallium-68-exendin

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beta cell mass	Pancreatic uptake of the tracer is measured by quantitative analysis (measure for beta cell mass)	2 years
Secondary	Beta cell mass vs. beta cell function	The correlation of the measured beta cell mass to the beta cell function	2 years