OverweightFATCORNCT02805478
Fat-Associated Cardiovascular Organ Dysfunction
An observational study of Overweight and Obesity, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
This is an observational study of cardiovascular risk factors and arterial or cardiac function in subjects with overweight or obesity. Subjects must be between 30 and 65 years of age, have a body mass index >27.0 kg/m2 and free from known heart disease and digestive or psychiatric disorders. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- How many people
- 618 participants
- Where
- 1 siteNorway
- Study dates
- 5 Sep 2009to 30 Apr 2017
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Norwegian women and men
Who may be able to join
- body mass index > 27.0 kg/m2
Who cannot join
- known heart disease
- digestive disorder
- psychiatric disorder
- unfamiliar with Norwegian language
Trial locations and contacts
1 site in 1 country.
Norway1 site
Haukeland University Hospital, Department of Heart Disease
Bergen, 5021
About this study
This is an observational study of cardiovascular risk factors and arterial or cardiac function in subjects with overweight or obesity. Subjects must be between 30 and 65 years of age, have a body mass index >27.0 kg/m2 and free from known heart disease and digestive or psychiatric disorders. Study aims include identifying sex-differences in traditional cardiovascular risk factors and structural and functional abnormalities in arteries and the heart in subjects with overweight or obesity, and how this is influenced by physical fitness.
Read the detailed description
FATCOR is an observational study of women and men with overweight or obesity. In particular prevalences of conventional cardiovascular risk factors and subclinical arterial or cardiac dysfunction are explored. The study aims at identifying sex differences in presence and clustering of cardiovascular risk factors and presence of subclinical cardiovascular organ damage. The influence of physical fitness on these factors will also be assessed. All participants undergo extensive cardiovascular risk factor assessment including oral glucose tolerance test and ambulatory blood pressure recording. Subclinical cardiovascular dysfunction is assessed by carotid and femoral vascular ultrasound, echocardiography and carotid-femoral pulse wave velocity using applanation tonometry. Physical fitness is assessed from peak oxygen uptake during maximal exercise testing on a treadmill.
- Conditions
- Overweight, Obesity
- Being tested
- There is no intervention
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no interventionOther
This is a prospective observational cohort study without any intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Abnormal left ventricular geometry
Echocardiography
Measured: At study baseline
Dilated left atrium
Echocardiography
Measured: At study baseline
Secondary outcomes (4)
Relation of physical fitness to prevalence of cardiovascular risk factors
Cardiopulmonary exercise
Measured: At study baseline
Relation of sex to prevalence of hypertension
Ambulatory blood pressure recording
Measured: At study baseline
Relation of sex to abnormal left ventricular geometry
Echocardiography
Measured: At study baseline
Relation of sex to arterial stiffness
Applanation tonometry
Measured: At study baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study start5 Sep 2009
- Primary completion30 Apr 2017
- Study completion30 Apr 2017
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 OverweightStudies 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
- 618 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kjell Vikenes, MD PhD, Study director, Haukeland University Hospital, Department of Heart Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02805478
- Sponsor's protocol ID
- 189.08
- Acronym
- FATCOR
- Status last verified
- Apr 2020
- First submitted
- 12 Jun 2016
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Halland H, Lonnebakken MT, Saeed S, Midtbo H, Cramariuc D, Gerdts E. Does fitness improve the cardiovascular risk profile in obese subjects? Nutr Metab Cardiovasc Dis. 2017 Jun;27(6):518-524. doi: 10.1016/j.numecd.2017.04.006. Epub 2017 Apr 26.
PubMed 28528703Halland H, Lonnebakken MT, Pristaj N, Saeed S, Midtbo H, Einarsen E, Gerdts E. Sex differences in subclinical cardiac disease in overweight and obesity (the FATCOR study). Nutr Metab Cardiovasc Dis. 2018 Oct;28(10):1054-1060. doi: 10.1016/j.numecd.2018.06.014. Epub 2018 Jun 21.
PubMed 30177273Halland H, Matre K, Einarsen E, Midtbo H, Saeed S, Pristaj N, Lonnebakken MT, Gerdts E. Effect of fitness on cardiac structure and function in overweight and obesity (the FATCOR study). Nutr Metab Cardiovasc Dis. 2019 Jul;29(7):710-717. doi: 10.1016/j.numecd.2019.03.012. Epub 2019 Apr 3.
PubMed 31138499Midtbo H, Ulvik A, Cramariuc D, Meyer K, Ueland PM, Halland H, Gerdts E. Influence of cardiorespiratory fitness on obesity-associated inflammation in women and men: The FATCOR study. Nutr Metab Cardiovasc Dis. 2024 Aug;34(8):1942-1949. doi: 10.1016/j.numecd.2024.04.002. Epub 2024 Apr 12.
PubMed 38749786Pristaj N, Saeed S, Midtbo H, Halland H, Matre K, Gerdts E. Covariables of Myocardial Function in Women and Men with Increased Body Mass Index. High Blood Press Cardiovasc Prev. 2020 Dec;27(6):579-586. doi: 10.1007/s40292-020-00418-6. Epub 2020 Oct 24.
PubMed 33098553Herfindal B, Gerdts E, Kringeland EA, Saeed S, Midtbo H, Halland H. Concomitant hypertension is associated with abnormal left ventricular geometry and lower systolic myocardial function in overweight participants: the FAT associated CardiOvasculaR dysfunction study. J Hypertens. 2020 Jun;38(6):1158-1164. doi: 10.1097/HJH.0000000000002397.
PubMed 32371806
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fat-Associated Cardiovascular Organ Dysfunction
- ClinicalTrials.gov ID
- NCT02805478
- Acronym / sponsor ID
- FATCOR / 189.08
- Conditions
- Overweight, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 618 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- 5 Sep 2009 (actual)
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 20 Jun 2016 (estimated)
- 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.
This is an observational study of cardiovascular risk factors and arterial or cardiac function in subjects with overweight or obesity. Subjects must be between 30 and 65 years of age, have a body mass index >27.0 kg/m2 and free from known heart disease and digestive or psychiatric disorders. Study aims include identifying sex-differences in traditional cardiovascular risk factors and structural and functional abnormalities in arteries and the heart in subjects with overweight or obesity, and how this is influenced by physical fitness.
Detailed description
FATCOR is an observational study of women and men with overweight or obesity. In particular prevalences of conventional cardiovascular risk factors and subclinical arterial or cardiac dysfunction are explored. The study aims at identifying sex differences in presence and clustering of cardiovascular risk factors and presence of subclinical cardiovascular organ damage. The influence of physical fitness on these factors will also be assessed. All participants undergo extensive cardiovascular risk factor assessment including oral glucose tolerance test and ambulatory blood pressure recording. Subclinical cardiovascular dysfunction is assessed by carotid and femoral vascular ultrasound, echocardiography and carotid-femoral pulse wave velocity using applanation tonometry. Physical fitness is assessed from peak oxygen uptake during maximal exercise testing on a treadmill.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Norwegian women and men
Key inclusion criteria (1 listed)
- body mass index > 27.0 kg/m2
Key exclusion criteria (4 listed)
- known heart disease
- digestive disorder
- psychiatric disorder
- unfamiliar with Norwegian language
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 |
|---|---|---|
| There is no interventionThis is a prospective observational cohort study without any intervention | Other | – |
Primary outcome
Abnormal left ventricular geometry
Time frame: At study baseline
Echocardiography
Dilated left atrium
Time frame: At study baseline
Echocardiography
4 secondary outcomes
Relation of physical fitness to prevalence of cardiovascular risk factors
Time frame: At study baseline
Relation of sex to prevalence of hypertension
Time frame: At study baseline
Relation of sex to abnormal left ventricular geometry
Time frame: At study baseline
Relation of sex to arterial stiffness
Time frame: At study baseline
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 4 Sep 2020.
- Results publication: PubMed 28528703Halland H, Lonnebakken MT, Saeed S, Midtbo H, Cramariuc D, Gerdts E. Does fitness improve the cardiovascular risk profile in obese subjects? Nutr Metab Cardiovasc Dis. 2017 Jun;27(6):518-524. doi: 10.1016/j.numecd.2017.04.006. Epub 2017 Apr 26.
- Results publication: PubMed 30177273Halland H, Lonnebakken MT, Pristaj N, Saeed S, Midtbo H, Einarsen E, Gerdts E. Sex differences in subclinical cardiac disease in overweight and obesity (the FATCOR study). Nutr Metab Cardiovasc Dis. 2018 Oct;28(10):1054-1060. doi: 10.1016/j.numecd.2018.06.014. Epub 2018 Jun 21.
- Results publication: PubMed 31138499Halland H, Matre K, Einarsen E, Midtbo H, Saeed S, Pristaj N, Lonnebakken MT, Gerdts E. Effect of fitness on cardiac structure and function in overweight and obesity (the FATCOR study). Nutr Metab Cardiovasc Dis. 2019 Jul;29(7):710-717. doi: 10.1016/j.numecd.2019.03.012. Epub 2019 Apr 3.
- Derived from this study: PubMed 38749786Midtbo H, Ulvik A, Cramariuc D, Meyer K, Ueland PM, Halland H, Gerdts E. Influence of cardiorespiratory fitness on obesity-associated inflammation in women and men: The FATCOR study. Nutr Metab Cardiovasc Dis. 2024 Aug;34(8):1942-1949. doi: 10.1016/j.numecd.2024.04.002. Epub 2024 Apr 12.
- Derived from this study: PubMed 33098553Pristaj N, Saeed S, Midtbo H, Halland H, Matre K, Gerdts E. Covariables of Myocardial Function in Women and Men with Increased Body Mass Index. High Blood Press Cardiovasc Prev. 2020 Dec;27(6):579-586. doi: 10.1007/s40292-020-00418-6. Epub 2020 Oct 24.
- Derived from this study: PubMed 32371806Herfindal B, Gerdts E, Kringeland EA, Saeed S, Midtbo H, Halland H. Concomitant hypertension is associated with abnormal left ventricular geometry and lower systolic myocardial function in overweight participants: the FAT associated CardiOvasculaR dysfunction study. J Hypertens. 2020 Jun;38(6):1158-1164. doi: 10.1097/HJH.0000000000002397.
- Individual participant dataSharing planned: Undecided
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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.
Kjell Vikenes, MD PhD study director
Haukeland University Hospital, Department of Heart Disease
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 Overweight and Obesity, run by Haukeland University Hospital at 1 site in Norway.
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 4 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 4 Sep 2020. 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 Norway. 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?
Abnormal left ventricular geometry (time frame: At study baseline). The study lists 2 primary outcomes in all. 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 NCT02805478, 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 4 Sep 2020.