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Study on Imaging Beta Cells in Patients with a History of Gestational Diabetes Using Exenatide

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on women who have experienced gestational diabetes, a type of diabetes that occurs during pregnancy. The study aims to explore how a special imaging technique can help visualize beta cells in the pancreas, which are responsible for producing insulin. The treatment involves using a substance called EXENATIDE, also known by its code name 68Ga-NODAGA-exendin-4, which is administered through an intravenous injection. This substance helps in capturing images of the pancreas using a method called PET/CT scan, which combines two types of imaging to provide detailed pictures of the body's internal structures.

The purpose of the study is to compare the accumulation of the Ga-exendin tracer in the pancreas of women with and without a history of gestational diabetes. This will help researchers understand the differences in beta cell function between these two groups. The study will involve a series of imaging sessions where participants will receive the tracer and undergo PET/CT scans to assess how the tracer accumulates in their pancreas.

Participants will be monitored over a period to observe any changes in the tracer's accumulation and to correlate these findings with the function of their beta cells. This research could provide valuable insights into the long-term effects of gestational diabetes on pancreatic function and help in developing better diagnostic and treatment strategies for managing diabetes in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, ensure that you meet the eligibility criteria. This includes having had a pregnancy with a diagnosis of gestational diabetes within the last five years, no other previous pregnancies, and complete resolution of gestational diabetes after delivery. Your blood sugar levels should be normal for at least one year without any medication or ongoing procedures. You must also provide signed informed consent.
Step 2
Initial assessment
An initial assessment will be conducted to gather baseline information. This may include a review of your medical history and a physical examination to ensure you meet all study requirements.
Step 3
Medication administration
You will receive a medication called exenatide through an intravenous bolus injection or IV infusion. This is a method of delivering the medication directly into your bloodstream. The specific dosage and frequency will be determined by the study team.
Step 4
Imaging procedure
A PET/CT scan will be performed to visualize the beta cells in your pancreas. This imaging procedure will help assess the accumulation of a tracer called 68Ga-exendin in your pancreas. The scan will provide detailed images for analysis.
Step 5
Follow-up assessments
Follow-up assessments will be conducted to monitor your health and gather additional data. These assessments may include further imaging or blood tests to evaluate the correlation between the tracer accumulation and beta cell function.
Step 6
Completion of study
Upon completion of the study, you will receive information about the findings and any relevant health insights. Your participation will contribute to understanding the differences in beta cell visualization in individuals with a history of gestational diabetes.

Who can join the trial?

5 criteria

Must have been pregnant and diagnosed with gestational diabetes (a type of diabetes that can develop during pregnancy) within the last 5 years.
Must not have had any other pregnancies.
Must have had a complete resolution of gestational diabetes after delivery, meaning:
- HbA1c (a blood test that shows average blood sugar levels over the past 3 months) must be in the normal range.
- Fasting glucose (blood sugar level after not eating for at least 8 hours) must be less than 100 mg/dl for at least 1 year without taking any diabetes medication or undergoing any procedures.
- Must have signed an informed consent form, which means you agree to participate in the study after being informed about all aspects of the trial.

Who cannot join the trial?

3 criteria

Patients who are not within the specified age range for the study.
Patients who are not female or male, as the study includes both genders.
Patients who are considered part of a vulnerable population. This means groups of people who might need special protection or care, such as children, pregnant women, or those with certain disabilities.

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Verified sites

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Stichting Radboud University Medical Center
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Nijmegen, The Netherlands

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Investigated drugs

68Ga-exendin is a special type of imaging agent used in this clinical trial. It helps doctors see the beta cells in the pancreas using a PET scan. Beta cells are important because they produce insulin, which helps control blood sugar levels. In this study, the researchers want to see how this imaging agent accumulates in the pancreas of people who have had gestational diabetes compared to those who have not. This can help them understand more about how gestational diabetes affects the pancreas and insulin production.

Exenatide

What is already known about the treatment

68Ga-exendin – This medication is administered through an injection and is used in a specialized imaging technique called PET (Positron Emission Tomography) to visualize certain cells in the pancreas. Currently, it is being studied in clinical trials to understand its effectiveness in patients with a history of gestational diabetes. The main purpose of using 68Ga-exendin is to help doctors see how the pancreas is functioning by highlighting specific areas during imaging. It works by binding to certain receptors on the surface of pancreatic cells, allowing them to be seen more clearly in PET scans. This medication is classified as a radiopharmaceutical, which means it is a radioactive compound used for diagnosis or treatment.

Investigated diseases

Gestational diabetes – Gestational diabetes is a condition characterized by high blood sugar levels that develop during pregnancy and usually disappear after giving birth. It occurs when the body cannot produce enough insulin to meet the extra needs of pregnancy. This condition can lead to increased blood sugar levels, which can affect the pregnancy and the baby's health. Typically, gestational diabetes develops in the second or third trimester. It may not cause noticeable symptoms, but some women may experience increased thirst or urination. The condition requires monitoring to manage blood sugar levels effectively.