Obesity Clinical Trial
— CUT-ITOfficial title:
Copenhagen Study of Obese Patients With Ischemic Heart Disease Undergoing Low Energy Diet or Interval Training: A Randomized Clinical Trial
The purpose of the study is to make a head-to-head comparison of weight loss and interval training as methods of secondary prevention in overweight patients with ischemic heart disease.
Status | Completed |
Enrollment | 70 |
Est. completion date | April 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 45 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Stable Ischemic Heart Disease - BMI 28 - 40 kg/m2 Exclusion criteria: - Known Diabetes Mellitus - Repeated Fasting plasma glucose = 7 mmol/L or Hba1c > 7 % - Severe or moderate valve disease - Main stem stenosis - Severe heart failure, Ejection Fraction < 35 % - Physical or mental disability which are expected to prevent completion of intervention - Severe Chronic obstructive Pulmonary Disease (COPD) (FEV1 < 50 % of expected) or asthma - Active cancer - Severe kidney (GFR < 40 ml/hour) or severe liver disease - Severe ischemia or arrhythmias during exercise test - 2. or 3. degree atrio-ventricular (AV) block, not protected by pacemaker - Organised training more than 2 times a week prior to inclusion - Significant weight loss or weight gain (> 5 %)3 month prior to inclusion - Not able to comprehend written and oral informed consent - Hormone treatment |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Denmark | Bispebjerg Hospital | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Eva Prescott | Amager Hospital, Bispebjerg Hospital, Copenhagen University Hospital at Herlev, Copenhagen University Hospital, Hvidovre, Rigshospitalet, Denmark, Texas A&M University, University of Aarhus, University of California, Davis, University of Copenhagen |
Denmark,
Pedersen LR, Olsen RH, Frederiksen M, Astrup A, Chabanova E, Hasbak P, Holst JJ, Kjær A, Newman JW, Walzem R, Wisløff U, Sajadieh A, Haugaard SB, Prescott E. Copenhagen study of overweight patients with coronary artery disease undergoing low energy diet or interval training: the randomized CUT-IT trial protocol. BMC Cardiovasc Disord. 2013 Nov 19;13:106. doi: 10.1186/1471-2261-13-106. — View Citation
Pedersen LR, Olsen RH, Jürs A, Astrup A, Chabanova E, Simonsen L, Wisløff U, Haugaard SB, Prescott E. A randomised trial comparing weight loss with aerobic exercise in overweight individuals with coronary artery disease: The CUT-IT trial. Eur J Prev Cardiol. 2015 Aug;22(8):1009-17. doi: 10.1177/2047487314545280. Epub 2014 Jul 31. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Coronary Flow Reserve following the diet or training intervention and a maintenance period | Assessed by a non-invasive echocardiographic Doppler measurement | 0, 12 and 52 weeks | No |
Secondary | Change in Heart Rate Variability and silent ischemia following the diet or training intervention and a maintenance period | Assessed by Holter Monitoring for 24 - 48 hours | 0, 12 and 52 weeks | No |
Secondary | Change in endothelial function following the diet or training intervention and a maintenance period | Using the Endopat 2000 from Itamar | 0, 12 and 52 weeks | No |
Secondary | Change in systolic and diastolic function following the diet or training intervention and a maintenance period | Assessed by echocardiography resting and during physiological and medical stress. | 0, 12 and 52 weeks | No |
Secondary | Change in body composition following the diet or training intervention and a maintenance period | Assessed by anthropometry, dual X-ray absorptiometry (DXA) (lean body mass, percentage adipose tissue) and abdominal MRI (liver fat, muscle fat, subcutaneous fat and visceral fat at the level of L3). | 0, 12 and 52 weeks | No |
Secondary | Change in myocardial blood flow following the diet or training intervention and a maintenance period | Assessed by positron emission tomography of the heart | 0, 12 and 52 weeks | No |
Secondary | Change in insulin action, beta cell function and incretin secretion following the diet or training intervention and a maintenance period | A Oral Glucose Tolerance Test is performed. | 0, 12 and 52 weeks | No |
Secondary | Change in oxidized lipids and lipoprotein particle size following the diet or training intervention and a maintenance period | 0, 12 and 52 weeks | No | |
Secondary | Change in peak oxygen uptake (VO2max) following the diet or training intervention and a maintenance period | Assessed using a bicycle ergometer | 0, 12 and 52 weeks | No |
Secondary | Change in blood pressure following the diet or training intervention and a maintenance period | 0, 12 and 52 weeks | No | |
Secondary | Change in inflammatory markers in urin, blood and adipose tissue following the diet or training intervention and a maintenance period | 0, 12 and 52 weeks | No | |
Secondary | Change in quality of life following the diet or training intervention and a maintenance period | 0, 12 and 52 weeks | No | |
Secondary | Change in ceramides, diacylglycerol og endocannabinoid (CB)-1 receptors in adipose tissue following the diet or training intervention and a maintenance period | 0, 12 and 52 weeks | No | |
Secondary | Change in hormones derived from adipose tissue following the diet or training intervention and a maintenance period | 0, 12 and 52 weeks | No |
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