Clinical trial NCT02805478: Fat-Associated Cardiovascular Organ Dysfunction
Official title: Fat-Associated Cardiovascular Organ Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overweight
Obesity
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2016-06-20
Enrollment: 618
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Norwegian women and men

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* body mass index \> 27.0 kg/m2

Exclusion Criteria:

* known heart disease
* digestive disorder
* psychiatric disorder
* unfamiliar with Norwegian language

Primary outcomes:
measure: Abnormal left ventricular geometry
timeFrame: At study baseline
measure: Dilated left atrium
timeFrame: At study baseline
Secondary outcomes:
measure: Relation of physical fitness to prevalence of cardiovascular risk factors
timeFrame: At study baseline
measure: Relation of sex to prevalence of hypertension
timeFrame: At study baseline
measure: Relation of sex to abnormal left ventricular geometry
timeFrame: At study baseline
measure: Relation of sex to arterial stiffness
timeFrame: At study baseline
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital, Department of Heart Disease
Study officials:
affiliation: Haukeland University Hospital, Department of Heart Disease
name: Kjell Vikenes, MD PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.