Copenhagen Study of Obese Patients With Ischemic Heart Disease Undergoing Low Energy Diet or Interval Training

Obesity Clinical Trial

— CUT-IT  

Official title:

Copenhagen Study of Obese Patients With Ischemic Heart Disease Undergoing Low Energy Diet or Interval Training: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01724567
• Other study ID #: CUT-IT
• Status: Completed
• Phase: N/A
• First received: October 26, 2012
• Last updated: August 3, 2014
• Start date: September 2011
• Est. completion date: April 2014

Study information

• Verified date: August 2014
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

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.

Description:

In western countries 80 % of patients with ischemic heart disease (IHD) are overweight (BMI > 25). Weight loss using a low energy diet (LED, 800 - 1000 kcal/day) has been shown to induce a considerable weight loss in obese but otherwise healthy patients and to reduce the risk of cardiovascular disease and diabetes in these subjects. Additionally, a British study using a very low energy diet (VLED, 600 kcal/day) to obtain weight loss, has shown that subject with diagnosed type 2 diabetes had their blood glucose normalized after an 8 week VLED. However, the effect of LED has never been examined in overweight patients with IHD.

Several studies have shown that patients with IHD have a beneficial effect of exercise training regarding mortality and reduction in cardiovascular risk factors. A Norwegian group has shown that aerobic interval training results in the biggest increase in maximal oxygen uptake (VO2max). A high VO2max is correlated to decreased mortality in patients with IHD.

In conclusion, weight loss and exercise are known strategies in preventing progression of IHD and development of type 2 diabetes in these patients, however a head-to-head comparison of the two methods has never been made and it is unknown which intervention is the most effective in improving cardiovascular risk profile. Furthermore, several mechanisms behind the known beneficial effect of these interventions are unknown.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemia
• Ischemic Heart Disease
• Myocardial Ischemia
• Obesity

Intervention

Other:
• Interval Training
Interval training (IT) on an exercise bike 3 times a week, for the first 12 weeks, followed by 40 weeks of IT 2 times a week on exercise bike. Each training session consists of active intervals with a total duration of 16 minutes (durations intervals between 1 and 4 minutes) at 90% of maximal heart rate. Active intervals are separated by active pauses at 60% of maximal heart rate.
• Weight Loss
Low calorie diet approx. 1000 kcal/day for 8 - 10 weeks to obtain a 10 - 15 % weight loss.

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen

Sponsors (10)

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

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

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

Outcome

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