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Completed

NCT Number: NCT02805478

Fat-Associated Cardiovascular Organ Dysfunction

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.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Haukeland University Hospital, Department of Heart Disease

Bergen, 5021, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • body mass index > 27.0 kg/m2

Exclusion criteria

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

Treatment and study plan

There is no intervention

Other

This is a prospective observational cohort study without any intervention

Primary outcomes

  1. Abnormal left ventricular geometry

    Time frame: At study baseline

    Echocardiography

  2. Dilated left atrium

    Time frame: At study baseline

    Echocardiography

Secondary outcomes

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

    Time frame: At study baseline

    Cardiopulmonary exercise

  2. Relation of sex to prevalence of hypertension

    Time frame: At study baseline

    Ambulatory blood pressure recording

  3. Relation of sex to abnormal left ventricular geometry

    Time frame: At study baseline

    Echocardiography

  4. Relation of sex to arterial stiffness

    Time frame: At study baseline

    Applanation tonometry

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Registry information

Acronym: FATCOR

Important dates

Study start
2009
Primary completion
2017
Study completion
2017
First posted
Jun 20, 2016
Registry last updated
Sep 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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