Fat-Associated Cardiovascular Organ Dysfunction

Completed

• Conditions: Obesity; Overweight

• Registration Number: NCT02805478
• Lead Sponsor: Haukeland University Hospital

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.

Study Timeline

• Study Start: 2009-09-05
• Study First Submitted: 2016-06-12
• Study First Submitted QC: 2016-06-17
• Study First Posted: 2016-06-20
• Primary Completion: 2017-04-30
• Study Completion: 2017-04-30
• Status Verified: 2020-04
• Last Update Submitted: 2020-09-01
• Last Update Posted: 2020-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 618

Inclusion Criteria

• body mass index > 27.0 kg/m2

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dilated left atrium	At study baseline	Echocardiography
Abnormal left ventricular geometry	At study baseline	Echocardiography

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Haukeland University Hospital, Department of Heart Disease; 🇳🇴 Bergen, Norway