Study on Verapamil and Exenatide for Adults with Type 1 Diabetes to Measure Changes in Beta Cell Mass

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What is this study about?

This clinical trial is focused on studying Type 1 Diabetes, a condition where the body’s immune system attacks the insulin-producing cells in the pancreas. The study will use a medication called Verapamil, which is a type of drug known as a calcium-channel blocker, and another substance called Exenatide, which is a protein-based medication. The purpose of the study is to explore how these treatments affect the mass of beta cells in the pancreas, which are responsible for producing insulin.

Participants in the study will undergo a special imaging process called PET/CT to measure how much of a substance called 68Ga-NODAGA-exendin is taken up by the pancreas. This will help researchers see the differences in beta cell mass before and after treatment, as well as compare results between those receiving the treatment and those receiving a placebo. The study will track these changes over a period of time to understand the effects of the treatments on the pancreas.

The study will involve regular imaging sessions to monitor changes in the pancreas, and these will be compared with other measurements related to insulin production, such as C-peptide and proinsulin levels. The goal is to gain insights into how these treatments might help preserve or improve the function of insulin-producing cells in people with Type 1 Diabetes.

1 initial assessment

Participation begins with an initial assessment to confirm eligibility. This includes verifying that the individual is part of the VER-A-T1D trial, has not started treatment or placebo, and has provided written informed consent. The individual must be at least 18 years old.

2 baseline imaging

A baseline PET/CT scan is conducted to measure the pancreatic uptake of a substance called 68Ga-NODAGA-exendin. This scan helps determine the initial beta cell mass.

3 medication administration

The individual receives verapamil orally and exenatide via intravenous bolus. The specific dosage and frequency are determined by the study protocol.

4 follow-up imaging

After 12 months, a follow-up PET/CT scan is performed to assess changes in the pancreatic uptake of 68Ga-NODAGA-exendin. This helps evaluate any differences in beta cell mass over time.

5 data analysis

The study analyzes the total pancreatic uptake of 68Ga-NODAGA-exendin to determine changes in beta cell mass. Secondary analyses include examining changes in C-peptide and proinsulin/preproinsulin levels, as well as differences in uptake between individuals and over time.

Who Can Join the Study?

  • Must be part of the VER-A-T1D trial but have not yet started treatment or received a placebo.
  • Must have given written informed consent, which means you agree to participate after being fully informed about the study.
  • Must be at least 18 years old at the time of giving consent.

Who Cannot Join the Study?

  • Individuals who do not have type 1 diabetes mellitus cannot participate. This is a condition where the body does not produce insulin, a hormone needed to control blood sugar levels.
  • Participants must be within certain age ranges, specifically between 18 and 65 years old.
  • Both males and females are eligible to participate.
  • Individuals who are considered part of a vulnerable population, such as those unable to give informed consent, are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medical University Of Vienna Vienna Austria

Other Sites

Site Name City Country Status
Hopital Tenon Paris France
Hopital Beaujon Clichy France
Mqocmel Uuhjqihlrv Oh Guae Graz Austria

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not yet recruiting
01.01.2021
France France
Not yet recruiting
01.01.2021

Trial locations

Investigated drugs:

68Ga-NODAGA-exendin is a special imaging agent used in this study. It helps doctors see how much of a certain type of cell, called beta cells, are in the pancreas. This is important because beta cells make insulin, which helps control blood sugar levels. The study uses a type of scan called PET/CT to take pictures of the pancreas before and after treatment to see if there are any changes in the number of beta cells.

Type 1 Diabetes Mellitus – This is a chronic condition where the pancreas produces little or no insulin, a hormone needed to allow sugar (glucose) to enter cells to produce energy. It typically appears in childhood or adolescence but can develop in adults. The immune system mistakenly attacks and destroys insulin-producing beta cells in the pancreas. As a result, blood sugar levels become elevated, leading to various symptoms such as increased thirst, frequent urination, hunger, fatigue, and blurred vision. Over time, high blood sugar levels can cause damage to various organs and tissues in the body. The progression of the disease requires careful management of blood sugar levels to maintain health.

Trial ID:
2024-518554-17-00
NCT ID:
NCT04615910
Trial Phase:
Therapeutic exploratory (Phase II)

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