Predictive Cardio-Metabolic Trascrictomics Trajectories in the Barilla Offspring Follow-Up Study

NCT06876818 | Active Not Recruiting

• 2 other identifiers: 604-20232022FZL247
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Experimental, drug-free, longitudinal, single-centre study for the prediction of cardiometabolic risk in Barilla Off-Spring Study subjects by analysing the evolution of transcriptomic signatures

Conditions

Healthy Volunteer

Keywords

transcriptomic analysis; cardio-metabolic analysis

Outcome Measures

Primary Outcomes (1)

• Selection of a set of candidate genes directly correlated with the development of altered metabolic phenotypes

  All data related to the transcriptomics of PBMCs at T0 (2006-2007) will be retrieved. At T1, a blood sample will be collected from which PBMCs will be isolated. Total RNA will be purified and its quality tested using the Quibit fluorimetric technique and the Tape-station system. From the same blood sample, the monocyte subpopulation will also be isolated and used to identify the specific transcriptomic signature. Both RNA datasets, collected at T0 and T1, will be processed to identify informative transcriptomic signatures of baseline and follow-up conditions. The sets will be converted to obtain a profile for a symbol gene; this will allow easier comparison of the calculated transcriptomic signatures between different datasets, facilitating the biological interpretation of the results.

  within six months of the enrolment visit

Secondary Outcomes (5)

• Selection of a set of candidate genes directly related to the development of altered vascular phenotypes

  within six months of the enrolment visit

• Selection of a set of candidate genes directly related to overt altered metabolic and/or vascular phenotypes.

  within six months of the enrolment visit

• Selection of markers directly related to the development of altered metabolic and/or vascular phenotypes.

  within six months of the enrolment visit

• Selection of a set of candidate genes directly related to alterations in biohumoral parameters and the inflammatory profile.

  within six months of the enrolment visit

• Selection of a set of candidate genes directly related to alterations in lifestyle.

  within six months of the enrolment visit

Study Arms (1)

Participants in the Barilla Offspring Study

Other: Evaluation of transcriptomic and cardio-metabolic profiles

Interventions

Evaluation of transcriptomic and cardio-metabolic profiles OTHER

The parameters and variables collected in 2006-2007 (T0) will be re-evaluated at the follow-up visit (T1), including demographic, anthropometric, lifestyle data (smoking habit, physical activity, sleep quality) blood pressure, standard biochemical analysis and inflammatory profile. To assess the evolution of glucose tolerance and vascular damage, metabolic (OGTT) and cardiovascular (carotid ecodoppler) profile analyses will be repeated. For gene expression analyses, in addition to messenger RNA from PBMCs (as at T0), RNA from PBMC-derived monocytes will also be extracted and sequenced at T1.

Participants in the Barilla Offspring Study

Eligibility Criteria

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

Study Population

healthy adults who participated in the cross-sectional Barilla Offspring Study in 2006-2007

You may qualify if:

• Being enrolled in the Barilla Off-Spring Study (2006-2007)
• Ability to understand the methods, aims and implications of the study, and to give free and informed consent

You may not qualify if:

• Pregnancy

Sponsors & Collaborators

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

Study Sites (1)

University of Parma, Department of Medicine and Surgery

Parma, PR, 43126, Italy

Location

Related Publications (6)

• Scazzina F, Dei Cas A, Del Rio D, Brighenti F, Bonadonna RC. The beta-cell burden index of food: A proposal. Nutr Metab Cardiovasc Dis. 2016 Oct;26(10):872-8. doi: 10.1016/j.numecd.2016.04.015. Epub 2016 May 6.

  PMID: 27381989 BACKGROUND

• Bianchi C, Miccoli R, Trombetta M, Giorgino F, Frontoni S, Faloia E, Marchesini G, Dolci MA, Cavalot F, Cavallo G, Leonetti F, Bonadonna RC, Del Prato S; GENFIEV Investigators. Elevated 1-hour postload plasma glucose levels identify subjects with normal glucose tolerance but impaired beta-cell function, insulin resistance, and worse cardiovascular risk profile: the GENFIEV study. J Clin Endocrinol Metab. 2013 May;98(5):2100-5. doi: 10.1210/jc.2012-3971. Epub 2013 Mar 28.

  PMID: 23539736 BACKGROUND

• Myhrstad MC, Ulven SM, Gunther CC, Ottestad I, Holden M, Ryeng E, Borge GI, Kohler A, Bronner KW, Thoresen M, Holven KB. Fish oil supplementation induces expression of genes related to cell cycle, endoplasmic reticulum stress and apoptosis in peripheral blood mononuclear cells: a transcriptomic approach. J Intern Med. 2014 Nov;276(5):498-511. doi: 10.1111/joim.12217. Epub 2014 Mar 20.

  PMID: 24641624 BACKGROUND

• Chi H. Immunometabolism at the intersection of metabolic signaling, cell fate, and systems immunology. Cell Mol Immunol. 2022 Mar;19(3):299-302. doi: 10.1038/s41423-022-00840-x. Epub 2022 Feb 21. No abstract available.

  PMID: 35190684 BACKGROUND

• Ahlqvist E, Storm P, Karajamaki A, Martinell M, Dorkhan M, Carlsson A, Vikman P, Prasad RB, Aly DM, Almgren P, Wessman Y, Shaat N, Spegel P, Mulder H, Lindholm E, Melander O, Hansson O, Malmqvist U, Lernmark A, Lahti K, Forsen T, Tuomi T, Rosengren AH, Groop L. Novel subgroups of adult-onset diabetes and their association with outcomes: a data-driven cluster analysis of six variables. Lancet Diabetes Endocrinol. 2018 May;6(5):361-369. doi: 10.1016/S2213-8587(18)30051-2. Epub 2018 Mar 5.

  PMID: 29503172 BACKGROUND

• Adeva-Andany MM, Martinez-Rodriguez J, Gonzalez-Lucan M, Fernandez-Fernandez C, Castro-Quintela E. Insulin resistance is a cardiovascular risk factor in humans. Diabetes Metab Syndr. 2019 Mar-Apr;13(2):1449-1455. doi: 10.1016/j.dsx.2019.02.023. Epub 2019 Feb 22.

  PMID: 31336505 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

PBMC, monocytes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 14, 2025
• Study Start: May 23, 2024
• Primary Completion: July 1, 2025
• Study Completion: December 31, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03

Locations

IT (1)