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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

Asset

Exenatide

GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

70

estimated

Study population

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

Key I/E criterion

Primary endpoints

BCF x MPancreatic beta cell mass (BCM)Pancreatic beta cell function (BCF)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. 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

Study populations

Who this study enrolls

Healthy volunteersPrediabetes / glucose intoleranceType 1 diabetesType 2 diabetes

Eligibility

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
2
Other (unclassified)
1

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 1, 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 1, 2026 snapshot.