Food (poly)phenol Metabotypes and Beta-cell Mass and Function.

NCT06888167 | Recruiting

• 1 other identifier: 683-2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Specific metabotypes (MTs) that associate with different pancreatic beta-cell mass and function (BCFxM).

  BCFxM=parametes derived from mixed meal test Beta cell function (BCF)=BCFxM/BCM

  through study completion, an average of 3 months after enrolment

Secondary Outcomes (4)

• Pancreatic beta cell mass (BCM)

  through study completion, an average of 3 months after enrolment

• Pancreatic beta cell function (BCF)

  through study completion, an average of 3 months after enrolment

• Specific MTs that exhibit different beta-cell mass (BCM) in vivo.

  through study completion, an average of 3 months after enrolment

• Personalized nutritional interventions.

  through study completion, an average of 3 months after enrolment

Study Arms (4)

Participants in the OPCT study - MT 'A', low disposition index (n=10)

OTHER

Other: Study setting

Participants in the OPCT study - MT 'A', high disposition index (n=10)

OTHER

Other: Study setting

Participants of the OPCT study - MT 'B', low disposition index (n=10)

OTHER

Other: Study setting

Participants of the OPCT study - MT 'B', high disposition index (n=10)

OTHER

Other: Study setting

Interventions

Study setting OTHER

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

Participants in the OPCT study - MT 'A', high disposition index (n=10); Participants in the OPCT study - MT 'A', low disposition index (n=10); Participants of the OPCT study - MT 'B', high disposition index (n=10); Participants of the OPCT study - MT 'B', low disposition index (n=10)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria di Parma: lead
• University of Parma: collaborator

Study Sites (1)

Azienda Ospedaliero-Universitaria di Parma

Parma, PR, Italy

RECRUITING

Related Publications (3)

• Rezania A, Bruin JE, Arora P, Rubin A, Batushansky I, Asadi A, O'Dwyer S, Quiskamp N, Mojibian M, Albrecht T, Yang YH, Johnson JD, Kieffer TJ. Reversal of diabetes with insulin-producing cells derived in vitro from human pluripotent stem cells. Nat Biotechnol. 2014 Nov;32(11):1121-33. doi: 10.1038/nbt.3033. Epub 2014 Sep 11.

  PMID: 25211370 BACKGROUND

• Blanchi B, Taurand M, Colace C, Thomaidou S, Audeoud C, Fantuzzi F, Sawatani T, Gheibi S, Sabadell-Basallote J, Boot FWJ, Chantier T, Piet A, Cavanihac C, Pilette M, Balguerie A, Olleik H, Carlotti F, Ejarque M, Fex M, Mulder H, Cnop M, Eizirik DL, Jouannot O, Gaffuri AL, Czernichow P, Zaldumbide A, Scharfmann R, Ravassard P. EndoC-betaH5 cells are storable and ready-to-use human pancreatic beta cells with physiological insulin secretion. Mol Metab. 2023 Oct;76:101772. doi: 10.1016/j.molmet.2023.101772. Epub 2023 Jul 11.

  PMID: 37442376 BACKGROUND

• Eriksson O, Velikyan I, Haack T, Bossart M, Laitinen I, Larsen PJ, Berglund JE, Antoni G, Johansson L, Pierrou S, Tillner J, Wagner M. Glucagonlike Peptide-1 Receptor Imaging in Individuals with Type 2 Diabetes. J Nucl Med. 2022 May;63(5):794-800. doi: 10.2967/jnumed.121.262506. Epub 2021 Sep 9.

  PMID: 34503957 BACKGROUND

Central Study Contacts

Alessandra Dei Cas, Prof.

CONTACT

+390521033321; alessandra.deicas@unipr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 21, 2025
• Study Start: October 14, 2024
• Primary Completion: December 31, 2025
• Study Completion: February 28, 2026
• Last Updated: March 21, 2025

Record last verified: 2025-03

Locations

IT (1)