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Open Access Highly Accessed Study protocol

Copenhagen study of overweight patients with coronary artery disease undergoing low energy diet or interval training: the randomized CUT-IT trial protocol

Lene Rørholm Pedersen1*, Rasmus Huan Olsen1, Marianne Frederiksen1, Arne Astrup2, Elizaveta Chabanova3, Philip Hasbak4, Jens Juul Holst5, Andreas Kjær4, John W Newman6, Rosemary Walzem7, Ulrik Wisløff8, Ahmad Sajadieh1, Steen Bendix Haugaard109 and Eva Prescott1

Author Affiliations

1 Department of Cardiology, Bispebjerg University Hospital, Copenhagen, Denmark

2 Department of Nutrition, Exercise, and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark

3 Department of Diagnostic Radiology, University Hospital of Herlev, Copenhagen, Denmark

4 Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine & PET, Copenhagen, Denmark

5 Faculty of Health and Medical Sciences, Department of Biomedical Sciences, Endocrinology Research Section, University of Copenhagen, Copenhagen, Denmark

6 Obesity and Metabolism Research Unit, USDA-ARS-Western Human Nutrition Research Center, Davis CA, USA

7 Faculty of Nutrition, Texas A&M University, College Station, TX, USA

8 K.G. Jebsen Center of Exercise in Medicine at Department of Circulation and Medical Imaging, Norwegian University of Science and Technology, Trondheim, Norway

9 Department of Internal Medicine, Amager University Hospital, Copenhagen, Denmark

10 Clinical Research Centre, Hvidovre University Hospital, Copenhagen, Denmark

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BMC Cardiovascular Disorders 2013, 13:106  doi:10.1186/1471-2261-13-106

Published: 19 November 2013

Abstract

Background

Coronary artery disease (CAD) is accountable for more than 7 million deaths each year according to the World Health Organization (WHO). In a European population 80% of patients diagnosed with CAD are overweight and 31% are obese. Physical inactivity and overweight are major risk factors in CAD, thus central strategies in secondary prevention are increased physical activity and weight loss.

Methods/Design

In a randomized controlled trial 70 participants with stable CAD, age 45–75, body mass index 28–40 kg/m2 and no diabetes are randomized (1:1) to 12 weeks of intensive exercise or weight loss both succeeded by a 40-week follow-up. The exercise protocol consist of supervised aerobic interval training (AIT) at 85-90% of VO2peak 3 times weekly for 12 weeks followed by supervised AIT twice weekly for 40 weeks. In the weight loss arm dieticians instruct the participants in a low energy diet (800–1000 kcal/day) for 12 weeks, followed by 40 weeks of weight maintenance combined with supervised AIT twice weekly. The primary endpoint of the study is change in coronary flow reserve after the first 12 weeks’ intervention. Secondary endpoints include cardiovascular, metabolic, inflammatory and anthropometric measures.

Discussion

The study will compare the short and long-term effects of a protocol consisting of AIT alone or a rapid weight loss followed by AIT. Additionally, it will provide new insight in mechanisms behind the benefits of exercise and weight loss. We wish to contribute to the creation of effective secondary prevention and sustainable rehabilitation strategies in the large population of overweight and obese patients diagnosed with CAD.

Trial registration

ClinicalTrials.gov: NCT01724567

Keywords:
Coronary artery disease; Secondary prevention; Rehabilitation; Exercise; Overweight; Obesity; Weight loss; Life style changes