Healthy VolunteerPREDICT-OMICSNCT06876818
Predictive Cardio-Metabolic Trascrictomics Trajectories In The Barilla Offspring Follow-Up Study
An observational study of Healthy Volunteer, run by Azienda Ospedaliero-Universitaria di Parma at 1 site in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Evaluation of transcriptomic and cardio-metabolic profiles
- How many people
- 110 participants
- Where
- 1 siteItaly
- Study dates
- 23 May 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy adults who participated in the cross-sectional Barilla Offspring Study in 2006-2007
Who may be able to join
- 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
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Italy1 site
University of Parma, Department of Medicine and Surgery
Parma, PR, 43126
About this study
Official title: Predictive Cardio-Metabolic Trascrictomics Trajectories In The Barilla Offspring Follow-Up STUDY: The PREDICT-OMICS Study.
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
Read the detailed description
In Westernized societies, common metabolic and cardiovascular diseases have complex etiologies involving dynamic genome-metagenome-environment interactions. The early molecular alterations that initiate and sustain their progression, although still only partially understood, are thought to share common roots in the terrain of insulin resistance (IR). In recent decades, reciprocal relationships between IR and inflammation have been unraveled, leading to the general concept of "meta-inflammation". In turn, the regulatory role played by metabolic signatures in immune cells has led to the concept of "immunometabolism". In particular, in these meta-inflammation-related disorders, there is a paucity of prospective gene expression data, especially in the early stages of their natural history. Gene expression profiling of peripheral blood mononuclear cells (PBMCs) may be a useful and accessible window into the pathophysiology of processes occurring in difficult-to-access organs and tissues. In a deeply phenotyped healthy cohort, the Barilla Offspring Study, a transcriptomic signature exclusively associated with IR was found by analyzing PBMC gene expression with a novel rank-based classification method, which was also found to discriminate diseased from healthy individuals in Alzheimer's disease, chronic heart failure and type 2 diabetes. The granularity of this approach can be further improved by examining gene expression in monocytes, as cells of innate immunity and mainly implicated in inflammatory/degenerative disorders and their risk factors. In this longitudinal study, we aim to identify the transcriptomic signature(s) in circulating immune cells and inflammatory biomarkers that predict or are associated with 15-year changes in glucose tolerance and/or carotid artery atherogenic phenotype. The study has solid premises: i. The cohort of subjects offers a unique opportunity to identify PBMC transcriptomic trajectories (baseline and 15-year follow-up) that predict changes in cardiometabolic phenotype; ii. cross-sectional assessment of monocyte transcriptomic profiling in the same cohort may uncover additional lineage-specific signatures associated with different cardio-metabotypes at follow-up, allowing comparison with PBMC; iii. an innovative rank-based classification method - SCUDO and its extensions - will be used, in addition to standard methods, to compute transcriptomic analyses. The results of the study may identify cellular transcriptomic signatures and trajectories, which could link cardiometabolic phenotypes at the molecular and cellular level, highlighting possible biological mechanisms of cardiometabolic disease susceptibility and progression, and unveiling a wide range of molecular targets in PBMC and, especially, monocytes, which can be further investigated for their validity as peripheral biomarkers for risk assessment. The findings will also provide new insights into targeted pharmacological strategies for the prevention and/or treatment of cardiometabolic diseases.
- Conditions
- Healthy Volunteer
- Being tested
- Evaluation of transcriptomic and cardio-metabolic profiles
- Keywords
- transcriptomic analysis, cardio-metabolic analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of transcriptomic and cardio-metabolic profilesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants in the Barilla Offspring Study | Not described Receives: Other: Evaluation of transcriptomic and cardio-metabolic profiles |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: within six months of the enrolment visit
Selection of a set of candidate genes directly related to overt altered metabolic and/or vascular 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.
Measured: within six months of the enrolment visit
Selection of markers directly related to the development of altered metabolic and/or vascular 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.
Measured: 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.
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.
Measured: within six months of the enrolment visit
Selection of a set of candidate genes directly related to alterations in lifestyle.
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.
Measured: within six months of the enrolment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start23 May 2024
- Primary completion1 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Parma
- Sponsor type
- University, hospital or other
- Collaborators
- University of Parma
- Responsible party
- Principal investigator, Alessandra Dei Cas, Azienda Ospedaliero-Universitaria di Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06876818
- Sponsor's protocol ID
- 604-2023
- Other IDs
- 2022FZL247
- Acronym
- PREDICT-OMICS
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27381989Bianchi 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.
PubMed 23539736Myhrstad 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.
PubMed 24641624Chi 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.
PubMed 35190684Ahlqvist 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.
PubMed 29503172Adeva-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.
PubMed 31336505
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Cardio-Metabolic Trascrictomics Trajectories In The Barilla Offspring Follow-Up STUDY: The PREDICT-OMICS Study.
- ClinicalTrials.gov ID
- NCT06876818
- Acronym / sponsor ID
- PREDICT-OMICS / 604-2023
- Conditions
- Healthy Volunteer
- Keywords
- transcriptomic analysis, cardio-metabolic analysis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ParmaUniversity, hospital or other
- Collaborators
- University of Parma
- Study start
- 23 May 2024 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
In Westernized societies, common metabolic and cardiovascular diseases have complex etiologies involving dynamic genome-metagenome-environment interactions. The early molecular alterations that initiate and sustain their progression, although still only partially understood, are thought to share common roots in the terrain of insulin resistance (IR). In recent decades, reciprocal relationships between IR and inflammation have been unraveled, leading to the general concept of "meta-inflammation". In turn, the regulatory role played by metabolic signatures in immune cells has led to the concept of "immunometabolism". In particular, in these meta-inflammation-related disorders, there is a paucity of prospective gene expression data, especially in the early stages of their natural history. Gene expression profiling of peripheral blood mononuclear cells (PBMCs) may be a useful and accessible window into the pathophysiology of processes occurring in difficult-to-access organs and tissues. In a deeply phenotyped healthy cohort, the Barilla Offspring Study, a transcriptomic signature exclusively associated with IR was found by analyzing PBMC gene expression with a novel rank-based classification method, which was also found to discriminate diseased from healthy individuals in Alzheimer's disease, chronic heart failure and type 2 diabetes. The granularity of this approach can be further improved by examining gene expression in monocytes, as cells of innate immunity and mainly implicated in inflammatory/degenerative disorders and their risk factors. In this longitudinal study, we aim to identify the transcriptomic signature(s) in circulating immune cells and inflammatory biomarkers that predict or are associated with 15-year changes in glucose tolerance and/or carotid artery atherogenic phenotype. The study has solid premises: i. The cohort of subjects offers a unique opportunity to identify PBMC transcriptomic trajectories (baseline and 15-year follow-up) that predict changes in cardiometabolic phenotype; ii. cross-sectional assessment of monocyte transcriptomic profiling in the same cohort may uncover additional lineage-specific signatures associated with different cardio-metabotypes at follow-up, allowing comparison with PBMC; iii. an innovative rank-based classification method - SCUDO and its extensions - will be used, in addition to standard methods, to compute transcriptomic analyses. The results of the study may identify cellular transcriptomic signatures and trajectories, which could link cardiometabolic phenotypes at the molecular and cellular level, highlighting possible biological mechanisms of cardiometabolic disease susceptibility and progression, and unveiling a wide range of molecular targets in PBMC and, especially, monocytes, which can be further investigated for their validity as peripheral biomarkers for risk assessment. The findings will also provide new insights into targeted pharmacological strategies for the prevention and/or treatment of cardiometabolic diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants in the Barilla Offspring Study | – | Other: Evaluation of transcriptomic and cardio-metabolic profiles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy adults who participated in the cross-sectional Barilla Offspring Study in 2006-2007
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of transcriptomic and cardio-metabolic profilesThe 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. | Other | Participants in the Barilla Offspring Study |
Primary outcome
Selection of a set of candidate genes directly correlated with the development of altered metabolic phenotypes
Time frame: within six months of the enrolment visit
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.
5 secondary outcomes
Selection of a set of candidate genes directly related to the development of altered vascular phenotypes
Time frame: within six months of the enrolment visit
Selection of a set of candidate genes directly related to overt altered metabolic and/or vascular phenotypes.
Time frame: within six months of the enrolment visit
Selection of markers directly related to the development of altered metabolic and/or vascular phenotypes.
Time frame: 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.
Time frame: within six months of the enrolment visit
Selection of a set of candidate genes directly related to alterations in lifestyle.
Time frame: within six months of the enrolment visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Results publication: PubMed 27381989Scazzina 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.
- Results publication: PubMed 23539736Bianchi 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.
- Results publication: PubMed 24641624Myhrstad 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.
- Results publication: PubMed 35190684Chi 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.
- Results publication: PubMed 29503172Ahlqvist 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.
- Results publication: PubMed 31336505Adeva-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.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteer, run by Azienda Ospedaliero-Universitaria di Parma at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Selection of a set of candidate genes directly correlated with the development of altered metabolic phenotypes (time frame: within six months of the enrolment visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06876818, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.