Clinical trial NCT01724567: Copenhagen Study of Obese Patients With Ischemic Heart Disease Undergoing Low Energy Diet or Interval Training
Official title: Copenhagen Study of Obese Patients With Ischemic Heart Disease Undergoing Low Energy Diet or Interval Training: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Heart Disease
Obesity
Keywords: Interval Training
Weight Loss
Secondary Prevention
Rehabilitation
Cardiovascular Risk Factors
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: Amager Hospital
name: Bispebjerg Hospital
name: Copenhagen University Hospital at Herlev
name: Copenhagen University Hospital, Hvidovre
name: Rigshospitalet, Denmark
name: University of California, Davis
name: Texas A&M University
name: University of Aarhus
First posted: 2012-11-12
Enrollment: 70
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Coronary Flow Reserve following the diet or training intervention and a maintenance period
timeFrame: 0, 12 and 52 weeks
Secondary outcomes:
measure: Change in Heart Rate Variability and silent ischemia following the diet or training intervention and a maintenance period
timeFrame: 0, 12 and 52 weeks
measure: Change in endothelial function following the diet or training intervention and a maintenance period
timeFrame: 0, 12 and 52 weeks
measure: Change in systolic and diastolic function following the diet or training intervention and a maintenance period
timeFrame: 0, 12 and 52 weeks
measure: Change in body composition following the diet or training intervention and a maintenance period
timeFrame: 0, 12 and 52 weeks
measure: Change in myocardial blood flow following the diet or training intervention and a maintenance period
timeFrame: 0, 12 and 52 weeks
measure: Change in insulin action, beta cell function and incretin secretion following the diet or training intervention and a maintenance period
timeFrame: 0, 12 and 52 weeks
measure: Change in oxidized lipids and lipoprotein particle size following the diet or training intervention and a maintenance period
timeFrame: 0, 12 and 52 weeks
measure: Change in peak oxygen uptake (VO2max) following the diet or training intervention and a maintenance period
timeFrame: 0, 12 and 52 weeks
measure: Change in blood pressure following the diet or training intervention and a maintenance period
timeFrame: 0, 12 and 52 weeks
measure: Change in inflammatory markers in urin, blood and adipose tissue following the diet or training intervention and a maintenance period
timeFrame: 0, 12 and 52 weeks
measure: Change in quality of life following the diet or training intervention and a maintenance period
timeFrame: 0, 12 and 52 weeks
measure: Change in ceramides, diacylglycerol og endocannabinoid (CB)-1 receptors in adipose tissue following the diet or training intervention and a maintenance period
timeFrame: 0, 12 and 52 weeks
measure: Change in hormones derived from adipose tissue following the diet or training intervention and a maintenance period
timeFrame: 0, 12 and 52 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
Study officials:
affiliation: Bispebjerg Hospital
name: Eva Prescott, MD, DMsc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pedersen LR, Olsen RH, Frederiksen M, Astrup A, Chabanova E, Hasbak P, Holst JJ, Kjaer A, Newman JW, Walzem R, Wisloff 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.
citation: Pedersen LR, Olsen RH, Jurs A, Astrup A, Chabanova E, Simonsen L, Wisloff 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.
citation: Pedersen LR, Olsen RH, Anholm C, Astrup A, Eugen-Olsen J, Fenger M, Simonsen L, Walzem RL, Haugaard SB, Prescott E. Effects of 1 year of exercise training versus combined exercise training and weight loss on body composition, low-grade inflammation and lipids in overweight patients with coronary artery disease: a randomized trial. Cardiovasc Diabetol. 2019 Oct 1;18(1):127. doi: 10.1186/s12933-019-0934-x.
citation: Pedersen LR, Olsen RH, Anholm C, Walzem RL, Fenger M, Eugen-Olsen J, Haugaard SB, Prescott E. Weight loss is superior to exercise in improving the atherogenic lipid profile in a sedentary, overweight population with stable coronary artery disease: A randomized trial. Atherosclerosis. 2016 Mar;246:221-8. doi: 10.1016/j.atherosclerosis.2016.01.001. Epub 2016 Jan 13.
citation: Pedersen LR, Olsen RH, Jurs A, Anholm C, Fenger M, Haugaard SB, Prescott E. A randomized trial comparing the effect of weight loss and exercise training on insulin sensitivity and glucose metabolism in coronary artery disease. Metabolism. 2015 Oct;64(10):1298-307. doi: 10.1016/j.metabol.2015.07.007. Epub 2015 Jul 17.
citation: Olsen RH, Pedersen LR, Jurs A, Snoer M, Haugaard SB, Prescott E. A randomised trial comparing the effect of exercise training and weight loss on microvascular function in coronary artery disease. Int J Cardiol. 2015 Apr 15;185:229-35. doi: 10.1016/j.ijcard.2015.03.118. Epub 2015 Mar 11.