Beta cell imaging in type 1 diabetes with stable near-normal and unstable glucose control using PET

Phase 2

Completed

• Conditions: Diabetes mellitus type 1; diabetes type 1; 10018424

• Registration Number: NL-OMON49309
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-06-21
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 16

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

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

- 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 <40 ml/min/1.73m^2
- Pregnancy or the wish to become pregnant within 6 months after the study
- Breastfeeding
- BMI <17 kg/m^2 or BMI >30 kg/m^2
- Age <18 years
- Inability to sign informed consent

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study objective is to determine residual beta cell mass in T1D<br /><br>patients with stable near-normal and unstable glucose control, as determined by<br /><br>measuring pancreatic uptake of Ga-68-exendin-4, to gain a better understanding<br /><br>of the relation between residual beta cell mass and glycemic control. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary aim is to correlate the measured residual beta cell mass to the<br /><br>beta cell function that will be determined by a mixed-meal tolerance test. </p><br>