Status:
TERMINATED
Beta Cell Imaging in T1D Patients With a Different Glycemic Control
Lead Sponsor:
Radboud University Medical Center
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Brief 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 unders...
Detailed 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 in...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 6 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 9 2020
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03785275
Start Date
December 6 2017
End Date
November 9 2020
Last Update
February 14 2022
Active Locations (1)
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1
Radboudumc
Nijmegen, Gelderland, Netherlands, 6525 GA