RecruitingPhase NA

Assessment of Pancreatic Beta Cell Mass and Function by Positron Emission Tomography Imaging in Human Diabetes Mellitus

Assessment of Pancreatic Beta Cell Mass and Function with the Aid of Positron Emission Tomography Imaging in Human Diabetes Mellitus

Lead sponsor

Azienda Ospedaliero-Universitaria di Parma

Asset

Exenatide

GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

Study population

Healthy volunteers, Prediabetes / glucose intolerance, Type 1 diabetes, Type 2 diabetes

Eligibility highlights

Primary endpoints

•BCF x M•Pancreatic beta cell mass (BCM)•Pancreatic beta cell function (BCF)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05662189

Org study ID462

Timeline

Milestones

Study start2022-03-15actual

Study first posted2022-12-22actual

Last update posted2025-03-18actual

Primary completion2025-07estimated (month precision)

Study completion2025-12estimated (month precision)

Assets

Investigational agents

Exenatide

Who this study enrolls

Healthy volunteersPrediabetes / glucose intoleranceType 1 diabetesType 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Age ≥18 years; ≤ 75 years

•Both sexes

•Good health

•Absence of exclusion criteria

•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

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Other (unclassified)

Glycemic / diabetes

2 endpoints

Primary/protocol endpoint/low confidence

BCF x M

Time frame:through study completion, an average of 3 months after enrolment

descriptive

Primary/protocol endpoint/low confidence

pancreatic beta cell function (BCF)

Time frame:through study completion, an average of 3 months after enrolment

descriptive, improvement

Other (unclassified)

1 endpoint

Primary/protocol endpoint/low confidence

pancreatic beta cell mass (BCM)

Time frame:through study completion, an average of 3 months after enrolment

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.