Cardiometabolic SyndromeNCT06284772
FINRISK 2002 Re-examination
An observational study of Cardiometabolic Syndrome and Cardiovascular Diseases, run by University of Turku at 1 site in Finland.
Trial summary
The project aims to fill in the existing gaps in the study of the microbiome as a cardiometabolic driver 1) by determining the key demographic, environmental, genetic, dietary, and metabolic correlates of long-term within-individual microbiome and microbial metabolite changes; and 2) by assessing how the gut… Read more about this study
- Who is it for?
- Ages 47 to 96 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiometabolic Syndrome, Cardiovascular Diseases
- What is being tested?
- Questionnaire and fecal sampling and Health examination
- How many people
- 2,500 participants
- Where
- 1 siteFinland
- Study dates
- 13 Nov 2023to 25 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 47 to 96 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The FINRISK 2002 cohort (N=7,237 participants with sequenced fecal samples) was originally examined in 2002. The FINRISK 2002 cohort is a random sample of the Finnish population, aged 25-74 years in the year 2002, from 6 geographic regions in Finland.
Who may be able to join
- Participation in FINRISK 2002 fecal sampling
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The project aims to fill in the existing gaps in the study of the microbiome as a cardiometabolic driver 1) by determining the key demographic, environmental, genetic, dietary, and metabolic correlates of long-term within-individual microbiome and microbial metabolite changes; and 2) by assessing how the gut microbiome, microbial metabolites, and their long-term changes are prospectively related to the risk factors, surrogate markers, and overt outcomes of CMD. To achieve this goal, repeat stool samples will be collected of ~2300 Finnish individuals who gave stool samples in the year 2002. In addition, ~300 individuals will undergo a in-depth health examination in 2024.
- Conditions
- Cardiometabolic Syndrome, Cardiovascular Diseases
- Being tested
- Questionnaire and fecal sampling, Health examination
- Medical subject headings
- Metabolic Syndrome, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and fecal samplingOther
The participants will be mailed a fecal collection kit and a 20-page health questionnaire. This questionnaire will include the similar questions concerning health, lifestyles, and diet as in 2002.
Health examinationOther
This examination will include measurements for anthropometrics, cognition (MoCA, Stroop, DSST), and blood pressure. The participants will undergo blood draw for laboratory analyses of CMD risk factors, such as blood lipids, glucose metabolism (fasting glucose, HbA1c, and fasting insulin), liver enzymes (GGT, ALT, and AST), inflammation (hs-CRP), and cardiac markers (proBNP and hs-TnI). We will perform ultrasound imaging for hepatic fibrosis.
| Study group | Role | What they receive |
|---|---|---|
| FINRISK 2002 re-examination cohort | All still-living FINRISK 2002 participants (~6000) were invited do participate in a re-examination >20 years after the initial fecal sampling. 2500 took part in the study. Receives: Other: Questionnaire and fecal sampling | |
| FINRISK 2002 re-examination health examination | The ~800 still-living participants from the Turku and Loimaa area were asked to participate in a health examination. 269 individuals took part in the health examination. Receives: Other: Questionnaire and fecal sampling; Other: Health examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiome change between 2002-2024
Individual-level changes in the metagenome-sequenced gut microbiome between 2002 and 2024. The microbiome indices of interest are:
- Alpha diversity
- Beta diversity
- Taxonomy
Measured: 2002-2024
Secondary outcomes (1)
Correlates of gut microbiome change between 2002-2024
Questionnaire-, biochemistry-, and health examination-derived correlates of gut microbiome change between 2002-2024.
Measured: 2002-2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start13 Nov 2023
- Primary completion25 Jun 2024
- Study completion25 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiometabolic SyndromeStudies 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
- Prospective
- Enrolment
- 2,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Collaborators
- Finnish Institute for Health and Welfare
- Responsible party
- Principal investigator, Teemu Niiranen, University of Turku
- Investigators
- Teemu Niiranen, MD, Principal investigator, Department of Internal Medicine, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284772
- Sponsor's protocol ID
- 4457/2023
- Status last verified
- Feb 2024
- First submitted
- 20 Feb 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Borodulin K, Tolonen H, Jousilahti P, Jula A, Juolevi A, Koskinen S, Kuulasmaa K, Laatikainen T, Mannisto S, Peltonen M, Perola M, Puska P, Salomaa V, Sundvall J, Virtanen SM, Vartiainen E. Cohort Profile: The National FINRISK Study. Int J Epidemiol. 2018 Jun 1;47(3):696-696i. doi: 10.1093/ije/dyx239. No abstract available.
PubMed 29165699Salosensaari A, Laitinen V, Havulinna AS, Meric G, Cheng S, Perola M, Valsta L, Alfthan G, Inouye M, Watrous JD, Long T, Salido RA, Sanders K, Brennan C, Humphrey GC, Sanders JG, Jain M, Jousilahti P, Salomaa V, Knight R, Lahti L, Niiranen T. Taxonomic signatures of cause-specific mortality risk in human gut microbiome. Nat Commun. 2021 May 11;12(1):2671. doi: 10.1038/s41467-021-22962-y.
PubMed 33976176
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FINRISK 2002 Re-examination
- ClinicalTrials.gov ID
- NCT06284772
- Acronym / sponsor ID
- 4457/2023
- Conditions
- Cardiometabolic Syndrome, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Collaborators
- Finnish Institute for Health and Welfare
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 25 Jun 2024 (actual)
- Study completion
- 25 Jun 2024 (actual)
- First posted
- 29 Feb 2024 (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.
The project aims to fill in the existing gaps in the study of the microbiome as a cardiometabolic driver 1) by determining the key demographic, environmental, genetic, dietary, and metabolic correlates of long-term within-individual microbiome and microbial metabolite changes; and 2) by assessing how the gut microbiome, microbial metabolites, and their long-term changes are prospectively related to the risk factors, surrogate markers, and overt outcomes of CMD. To achieve this goal, repeat stool samples will be collected of ~2300 Finnish individuals who gave stool samples in the year 2002. In addition, ~300 individuals will undergo a in-depth health examination in 2024.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FINRISK 2002 re-examination cohort | – | Other: Questionnaire and fecal samplingAll still-living FINRISK 2002 participants (~6000) were invited do participate in a re-examination >20 years after the initial fecal sampling. 2500 took part in the study. |
| FINRISK 2002 re-examination health examination | – | Other: Questionnaire and fecal sampling, Other: Health examinationThe ~800 still-living participants from the Turku and Loimaa area were asked to participate in a health examination. 269 individuals took part in the health examination. |
Who may qualify
- Ages
- 47 to 96 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The FINRISK 2002 cohort (N=7,237 participants with sequenced fecal samples) was originally examined in 2002. The FINRISK 2002 cohort is a random sample of the Finnish population, aged 25-74 years in the year 2002, from 6 geographic regions in Finland.
Key inclusion criteria (1 listed)
- Participation in FINRISK 2002 fecal sampling
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Questionnaire and fecal samplingThe participants will be mailed a fecal collection kit and a 20-page health questionnaire. This questionnaire will include the similar questions concerning health, lifestyles, and diet as in 2002. | Other | FINRISK 2002 re-examination cohort, FINRISK 2002 re-examination health examination |
| Health examinationThis examination will include measurements for anthropometrics, cognition (MoCA, Stroop, DSST), and blood pressure. The participants will undergo blood draw for laboratory analyses of CMD risk factors, such as blood lipids, glucose metabolism (fasting glucose, HbA1c, and fasting insulin), liver enzymes (GGT, ALT, and AST), inflammation (hs-CRP), and cardiac markers (proBNP and hs-TnI). We will perform ultrasound imaging for hepatic fibrosis. | Other | FINRISK 2002 re-examination health examination |
Primary outcome
Gut microbiome change between 2002-2024
Time frame: 2002-2024
Individual-level changes in the metagenome-sequenced gut microbiome between 2002 and 2024. The microbiome indices of interest are: 1. Alpha diversity 2. Beta diversity 3. Taxonomy
1 secondary outcome
Correlates of gut microbiome change between 2002-2024
Time frame: 2002-2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Background: PubMed 29165699Borodulin K, Tolonen H, Jousilahti P, Jula A, Juolevi A, Koskinen S, Kuulasmaa K, Laatikainen T, Mannisto S, Peltonen M, Perola M, Puska P, Salomaa V, Sundvall J, Virtanen SM, Vartiainen E. Cohort Profile: The National FINRISK Study. Int J Epidemiol. 2018 Jun 1;47(3):696-696i. doi: 10.1093/ije/dyx239. No abstract available.
- Background: PubMed 33976176Salosensaari A, Laitinen V, Havulinna AS, Meric G, Cheng S, Perola M, Valsta L, Alfthan G, Inouye M, Watrous JD, Long T, Salido RA, Sanders K, Brennan C, Humphrey GC, Sanders JG, Jain M, Jousilahti P, Salomaa V, Knight R, Lahti L, Niiranen T. Taxonomic signatures of cause-specific mortality risk in human gut microbiome. Nat Commun. 2021 May 11;12(1):2671. doi: 10.1038/s41467-021-22962-y.
- Individual participant dataSharing planned: No
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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.
Teemu Niiranen, MD principal investigator
Department of Internal Medicine, University of Turku
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 Cardiometabolic Syndrome and Cardiovascular Diseases, run by University of Turku at 1 site in Finland.
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 1 inclusion and 0 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: finished, as of the sponsor's last update on 9 Dec 2024. 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 Finland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Gut microbiome change between 2002-2024 (time frame: 2002-2024). 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 NCT06284772, which also lists 2 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 9 Dec 2024.