Fat-Associated Cardiovascular Organ Dysfunction

Obesity Clinical Trial

— FATCOR  

Official title:

Fat-Associated Cardiovascular Organ Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02805478
• Other study ID #: 189.08
• Status: Completed
• Start date: September 5, 2009
• Est. completion date: April 30, 2017

Study information

• Verified date: April 2020
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 618
• Est. completion date: April 30, 2017
• Est. primary completion date: April 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• body mass index > 27.0 kg/m2

Exclusion Criteria:

• known heart disease

• digestive disorder

• psychiatric disorder

• unfamiliar with Norwegian language

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Other:
• There is no intervention
This is a prospective observational cohort study without any intervention

Locations

Country	Name	City	State
Norway	Haukeland University Hospital, Department of Heart Disease	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (3)

Halland H, Lønnebakken MT, Pristaj N, Saeed S, Midtbø 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 — View Citation

Halland H, Lønnebakken MT, Saeed S, Midtbø 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. — View Citation

Halland H, Matre K, Einarsen E, Midtbø H, Saeed S, Pristaj N, Lønnebakken 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.num — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abnormal left ventricular geometry	Echocardiography	At study baseline
Primary	Dilated left atrium	Echocardiography	At study baseline
Secondary	Relation of physical fitness to prevalence of cardiovascular risk factors	Cardiopulmonary exercise	At study baseline
Secondary	Relation of sex to prevalence of hypertension	Ambulatory blood pressure recording	At study baseline
Secondary	Relation of sex to abnormal left ventricular geometry	Echocardiography	At study baseline
Secondary	Relation of sex to arterial stiffness	Applanation tonometry	At study baseline