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Recruiting Not applicable

Food (Poly)Phenol Metabotypes and Beta-cell Mass and Function.

NCT06888167 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2024-10-14
Last updated
2025-03-21

Condition(s) studied

Healthy Volunteer

Investigational drug(s) / intervention(s)

Study setting

Study setting: The subjects in the study will undergo two days of visits, in random order. 1. Following a fasting period of at least 4 hours, the study participants will undergo a PET-CT examination with Ga-exadin-4. Fasting will reduce the endogenous secretion of GLP-1 by the small intestine, which can otherwise compete with exendin-4 for binding to GLP-1R. Blood glucose will be measured before the injection of the tracer and monitored at each time point. 2. On a fasting basis, the anthropometric data of the enrolled subjects will be collected and they will undergo a short interview on their lifestyle. Subsequently, at time 0, the subjects will ingest a standard mixed meal consisting of 2 commercially available "ABC Parmareggio" snacks. Venous blood samples will be taken at specific time intervals (from -20 to 300 minutes) to measure glucose, C-peptide, insulin, glucagon, GLP-1 and glucose-dependent insulinotropic (GIP) curves. An additional blood sample will be taken at time -10 in order to isolate

Study summary

Cross-sectional, single-centre, 'low intervention' clinical study, without drug or medical device testing, with low-risk diagnostic technique.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Having been enrolled in the OPCT study; * Ability to understand the methods, purposes and implications of the study, and to give free and informed consent. Exclusion Criteria: * Pregnancy or breastfeeding; * Previous exposure to ionizing radiation in research programs; * History of psychiatric illness or alcohol abuse; * Head trauma; * Active neurological disease; * Claustrophobia; * Active malignant neoplastic disease.

Primary outcome measure(s)

  • Specific metabotypes (MTs) that associate with different pancreatic beta-cell mass and function (BCFxM). — through study completion, an average of 3 months after enrolment
    BCFxM=parametes derived from mixed meal test Beta cell function (BCF)=BCFxM/BCM

Trial sites (1)

FacilityCityRegionStatus
Azienda Ospedaliero-Universitaria di Parma Parma PR Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06888167 on ClinicalTrials.gov ↗ ← All trials in Italy