Fat-Associated Cardiovascular Organ Dysfunction (FATCOR)

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Other: There is no intervention

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 Type: Observational
• Enrollment (Actual): 618

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway, 5021
    • Haukeland University Hospital, Department of Heart Disease

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Norwegian women and men

Description

Inclusion Criteria:

• body mass index > 27.0 kg/m2

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abnormal left ventricular geometry	Echocardiography	At study baseline
Dilated left atrium	Echocardiography	At study baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relation of physical fitness to prevalence of cardiovascular risk factors	Cardiopulmonary exercise	At study baseline
Relation of sex to prevalence of hypertension	Ambulatory blood pressure recording	At study baseline
Relation of sex to abnormal left ventricular geometry	Echocardiography	At study baseline
Relation of sex to arterial stiffness	Applanation tonometry	At study baseline

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Investigators: Study Director: Kjell Vikenes, MD PhD, Haukeland University Hospital, Department of Heart Disease

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2009
• Primary Completion (Actual): April 30, 2017
• Study Completion (Actual): April 30, 2017

Study Registration Dates

• First Submitted: June 12, 2016
• First Submitted That Met QC Criteria: June 17, 2016
• First Posted (Estimate): June 20, 2016

Study Record Updates

• Last Update Posted (Actual): September 4, 2020
• Last Update Submitted That Met QC Criteria: September 1, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: 189.08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED