Diabetes mellitus type 1 diabetes type 1
Conditions
Interventions
Beta cell mass
Exendin
Glycemic control
Type 1 diabetes
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: T1D patients with stable near-normal glucose control: - Age *18 years - T1D diagnosed *1 year at the start of the study - HbA1c *7 (*53 mmol/mol) - 17* BMI *30 kg/m^2 - No severe hypoglycemic events in the past year and a maximum of 2 severe hypoglycemic events in their entire life. - Intact hypoglycemic awareness as assessed by a score of 0 or 1 on the modified Clarke*s questionnaire - Ability to sign informed consent Inclusion criteria: T1D patients with unstable glucose control: - Age *18 years - T1D diagnosed *1 year at the start of the study - Ability to sign informed consent - Option 1: HbA1c *8.5 (*69 mmol/mol) and in addition a minimum of 2 severe hypoglycemic events in the past year, or an impaired awareness of hypoglycemia (IHA), as assessed by a score of 2 or more on the modified Clarke*s questionnaire (subjects may comply with both criteria, but this is not a requirement). Option 2: HbA1c *8.0 (*64 mmol/mol) and in addition a minimum of 2 severe hypoglycemic events in the past year, or an impaired awareness of hypoglycemia (IHA), as assessed by a score of 3 or more on the modified Clarke*s questionnaire (subjects may comply with both criteria, but this is not a requirement) - 17* BMI *30 kg/m^2
Exclusion criteria
Exclusion criteria: Exclusion criteria: - Previous treatment (within 6 months) with synthetic Exendin (Exenatide, Byetta®) or Dipeptidyl-Peptidase IV inhibitors - Liver disease defined as aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range - Renal disease defined as MDRD 30 kg/m^2 - Age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study objective is to determine residual beta cell mass in T1D patients with stable near-normal and unstable glucose control, as determined by measuring pancreatic uptake of Ga-68-exendin-4, to gain a better understanding of the relation between residual beta cell mass and glycemic control. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary aim is to correlate the measured residual beta cell mass to the beta cell function that will be determined by a mixed-meal tolerance test. | — |
Countries
The Netherlands
Outcome results
None listed