Fat-Associated Cardiovascular Organ Dysfunction

NCT ID: NCT02805478

Last Updated: 2020-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

618 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-05

Study Completion Date

2017-04-30

Brief Summary

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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

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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.

Conditions

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Overweight Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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There is no intervention

This is a prospective observational cohort study without any intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* body mass index \> 27.0 kg/m2

Exclusion Criteria

* known heart disease
* digestive disorder
* psychiatric disorder
* unfamiliar with Norwegian language
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Haukeland University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kjell Vikenes, MD PhD

Role: STUDY_DIRECTOR

Haukeland University Hospital, Department of Heart Disease

Locations

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Haukeland University Hospital, Department of Heart Disease

Bergen, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type RESULT
PMID: 28528703 (View on PubMed)

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.

Reference Type RESULT
PMID: 30177273 (View on PubMed)

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.

Reference Type RESULT
PMID: 31138499 (View on PubMed)

Midtbo H, Ulvik A, Cramariuc D, Meyer K, Ueland PM, Halland H, Gerdts E. Influence of cardiorespiratory fitness on obesity-associated inflammation in women and men: The FATCOR study. Nutr Metab Cardiovasc Dis. 2024 Aug;34(8):1942-1949. doi: 10.1016/j.numecd.2024.04.002. Epub 2024 Apr 12.

Reference Type DERIVED
PMID: 38749786 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33098553 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32371806 (View on PubMed)

Other Identifiers

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189.08

Identifier Type: -

Identifier Source: org_study_id

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