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New treatment option for Type1diabetes
Official title Assessment of Pancreatic Beta Cell Mass and Function by Positron Emission Tomography Imaging in Human Diabetes Mellitus
ClinicalTrials.gov ID: NCT05662189
What this study is testing
What is 68Ga-exendin-4?
68Ga-exendin-4 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for type1diabetes.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goals of this project are to build an experimental tool to dissect out in vivo pancreatic beta cell mass (BCM) and beta cell function (BCF) and to assess for the first time these two determinants of beta cell functional mass (BCFxM) in obesity and in various stages of type 1 and type 2 diabetes mellitus.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age ≥18 years; ≤ 75 years
- Both sexes
- Good health
- Absence of
You likely can't join if
- Able to understand methods, goals, and implications of the research and of delivering a free, written informed consent Exclusion Criteria:
- Hemoglobin \< 12 g/dl
- HbA1c \> 10%
- Pregnancy or breast-feeding
- If not in menopause, women not using effective birth control methods or not willing to undergo a pregnancy test
- History of severe psychiatric disorder or alcohol abuse
See the full eligibility criteria
- Age ≥18 years; ≤ 75 years
- Both sexes
- Good health
- Absence of
- Able to understand methods, goals, and implications of the research and of delivering a free, written informed consent Exclusion Criteria:
- Hemoglobin \< 12 g/dl
- HbA1c \> 10%
- Pregnancy or breast-feeding
- If not in menopause, women not using effective birth control methods or not willing to undergo a pregnancy test
- History of severe psychiatric disorder or alcohol abuse
- Recent head traumas (\<6 months)
- Active neurologic diseases
- Claustrophobia
- Active malignant neoplasms
- Severe kidney and/or liver disease
- Recent (\<6 months) major adverse cardiovascular events
- Heart failure (class NYHA 3-4)
- Drugs known to affect beta cell function and/or insulin sensitivity
- Current or past treatment with GLP1R-agonists
- Intolerance to exenatide
- Endocrine diseases, other than diabetes mellitus, known to affect beta cell function and/or insulin sensitivity, except well controlled hypothyroidism or adrenal insufficiency
- COPD on day time oxygen therapy
- Any current acute disease
The study team makes the final eligibility decision.
Where it's taking place
- Parma, Pr, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Parma, Pr, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.