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CompletedNCT02805478FATCORUpdated Sep 4, 2020

Fat-Associated Cardiovascular Organ Dysfunction

An observational study in Overweight and Obesity, sponsored by Haukeland University Hospital. Completed at 1 site in Norway. Open to participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-04.

Sponsored by Haukeland University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
618
Ages
30 Years to 65 Years
Sex
All
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Study 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. 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.

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Conditions studied

  • Overweight
  • Obesity

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03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 850 are open to participants now.

This study's enrollment of 618 is above the median of 150 across 436 observational studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Haukeland University Hospital is the lead sponsor of 276 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Norwegian women and men

Inclusion criteria

  • body mass index > 27.0 kg/m2

Exclusion criteria

Exclusion Criteria:

  • known heart disease
  • digestive disorder
  • psychiatric disorder
  • unfamiliar with Norwegian language
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
618 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • OtherThere is no intervention

    This is a prospective observational cohort study without any intervention

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What researchers measure

Primary outcomes

  1. Abnormal left ventricular geometry

    Echocardiography

    Time frame: At study baseline

  2. Dilated left atrium

    Echocardiography

    Time frame: At study baseline

Secondary outcomes

  1. Relation of physical fitness to prevalence of cardiovascular risk factors

    Cardiopulmonary exercise

    Time frame: At study baseline

  2. Relation of sex to prevalence of hypertension

    Ambulatory blood pressure recording

    Time frame: At study baseline

  3. Relation of sex to abnormal left ventricular geometry

    Echocardiography

    Time frame: At study baseline

  4. Relation of sex to arterial stiffness

    Applanation tonometry

    Time frame: At study baseline

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Study locations

1 site
  • Haukeland University Hospital, Department of Heart Disease
    Bergen, 5021, Norway
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References and documents

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 28528703 ↗
  • Halland 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 30177273 ↗
  • Halland 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 31138499 ↗
  • Pristaj 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 33098553 ↗
  • Herfindal 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 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02805478
Lead sponsor
Haukeland University Hospital
Responsible party
Sponsor
First posted
Jun 20, 2016
Start date
Sep 5, 2009
Primary completion
Apr 30, 2017
Completion
Apr 30, 2017
Last update
Sep 4, 2020

Study contacts

Kjell Vikenes, MD PhD
study director · Haukeland University Hospital, Department of Heart Disease

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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