Ischemic Heart DiseaseCUT-ITNCT01724567
Copenhagen Study of Obese Patients With Ischemic Heart Disease Undergoing Low Energy Diet or Interval Training
A study testing Interval Training and Weight Loss in people with Ischemic Heart Disease and Obesity, run by Eva Prescott at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Ischemic Heart Disease, Obesity
- What is being tested?
- Interval Training and Weight Loss
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2011to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable Ischemic Heart Disease
- BMI 28 - 40 kg/m2
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
Read the 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.
- Conditions
- Ischemic Heart Disease, Obesity
- Being tested
- Interval Training, Weight Loss
- Keywords
- Interval Training, Weight Loss, Secondary Prevention, Rehabilitation, Cardiovascular Risk Factors
- Medical subject headings
- Myocardial Ischemia, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interval TrainingOther
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 LossOther
Low calorie diet approx. 1000 kcal/day for 8 - 10 weeks to obtain a 10 - 15 % weight loss.
| Study group | Role | What they receive |
|---|---|---|
| Weight Loss | Experimental | 12 weeks of Low Calorie Diet to obtain a 10 - 15 % weight loss. Followed by 40 weeks on a weight maintenance diet and interval training 2 times a week. Receives: Other: Weight Loss |
| Interval Training | Experimental | 12 weeks of interval training 3 times a week followed by 40 weeks of interval training 2 times a week. Receives: Other: Interval Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Coronary Flow Reserve following the diet or training intervention and a maintenance period
Assessed by a non-invasive echocardiographic Doppler measurement
Measured: 0, 12 and 52 weeks
Secondary outcomes (13)
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
Measured: 0, 12 and 52 weeks
Change in endothelial function following the diet or training intervention and a maintenance period
Using the Endopat 2000 from Itamar
Measured: 0, 12 and 52 weeks
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.
Measured: 0, 12 and 52 weeks
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).
Measured: 0, 12 and 52 weeks
Change in myocardial blood flow following the diet or training intervention and a maintenance period
Assessed by positron emission tomography of the heart
Measured: 0, 12 and 52 weeks
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.
Measured: 0, 12 and 52 weeks
Change in oxidized lipids and lipoprotein particle size following the diet or training intervention and a maintenance period
Measured: 0, 12 and 52 weeks
Change in peak oxygen uptake (VO2max) following the diet or training intervention and a maintenance period
Assessed using a bicycle ergometer
Measured: 0, 12 and 52 weeks
Change in blood pressure following the diet or training intervention and a maintenance period
Measured: 0, 12 and 52 weeks
Change in inflammatory markers in urin, blood and adipose tissue following the diet or training intervention and a maintenance period
Measured: 0, 12 and 52 weeks
Change in quality of life following the diet or training intervention and a maintenance period
Measured: 0, 12 and 52 weeks
Change in ceramides, diacylglycerol og endocannabinoid (CB)-1 receptors in adipose tissue following the diet or training intervention and a maintenance period
Measured: 0, 12 and 52 weeks
Change in hormones derived from adipose tissue following the diet or training intervention and a maintenance period
Measured: 0, 12 and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2012 (estimated)
- Study startSep 2011
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eva Prescott
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Amager Hospital, Bispebjerg Hospital, Copenhagen University Hospital at Herlev, Copenhagen University Hospital, Hvidovre, Copenhagen University Hospital, Rigshospitalet, University of California, Davis, Texas A&M University, University of Aarhus
- Responsible party
- Sponsor-investigator, Eva Prescott, Bispebjerg Hospital
- Investigators
- Eva Prescott, MD, DMsc, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01724567
- Sponsor's protocol ID
- CUT-IT
- Acronym
- CUT-IT
- Status last verified
- Aug 2014
- First submitted
- 26 Oct 2012
- Last updated
- 5 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24252596Pedersen 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.
PubMed 25082954Pedersen 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.
PubMed 31575375Pedersen 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.
PubMed 26803431Pedersen 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.
PubMed 26296452Olsen 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.
PubMed 25802037
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Copenhagen Study of Obese Patients With Ischemic Heart Disease Undergoing Low Energy Diet or Interval Training: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01724567
- Acronym / sponsor ID
- CUT-IT / CUT-IT
- Conditions
- Ischemic Heart Disease, Obesity
- Keywords
- Interval Training, Weight Loss, Secondary Prevention, Rehabilitation, Cardiovascular Risk Factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Eva PrescottUniversity, hospital or other
- Collaborators
- University of Copenhagen, Amager Hospital, Bispebjerg Hospital, Copenhagen University Hospital at Herlev, Copenhagen University Hospital, Hvidovre, Copenhagen University Hospital, Rigshospitalet, University of California, Davis, Texas A&M University, University of Aarhus
- Study start
- Sep 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 12 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weight Loss | Experimental | Other: Weight Loss12 weeks of Low Calorie Diet to obtain a 10 - 15 % weight loss. Followed by 40 weeks on a weight maintenance diet and interval training 2 times a week. |
| Interval Training | Experimental | Other: Interval Training12 weeks of interval training 3 times a week followed by 40 weeks of interval training 2 times a week. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stable Ischemic Heart Disease
- BMI 28 - 40 kg/m2
Key exclusion criteria (15 listed)
- 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 %
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interval TrainingInterval 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. | Other | Interval Training |
| Weight LossLow calorie diet approx. 1000 kcal/day for 8 - 10 weeks to obtain a 10 - 15 % weight loss. | Other | Weight Loss |
Primary outcome
Change in Coronary Flow Reserve following the diet or training intervention and a maintenance period
Time frame: 0, 12 and 52 weeks
Assessed by a non-invasive echocardiographic Doppler measurement
13 secondary outcomes
Change in Heart Rate Variability and silent ischemia following the diet or training intervention and a maintenance period
Time frame: 0, 12 and 52 weeks
Change in endothelial function following the diet or training intervention and a maintenance period
Time frame: 0, 12 and 52 weeks
Change in systolic and diastolic function following the diet or training intervention and a maintenance period
Time frame: 0, 12 and 52 weeks
Change in body composition following the diet or training intervention and a maintenance period
Time frame: 0, 12 and 52 weeks
Change in myocardial blood flow following the diet or training intervention and a maintenance period
Time frame: 0, 12 and 52 weeks
Change in insulin action, beta cell function and incretin secretion following the diet or training intervention and a maintenance period
Time frame: 0, 12 and 52 weeks
Change in oxidized lipids and lipoprotein particle size following the diet or training intervention and a maintenance period
Time frame: 0, 12 and 52 weeks
Change in peak oxygen uptake (VO2max) following the diet or training intervention and a maintenance period
Time frame: 0, 12 and 52 weeks
Change in blood pressure following the diet or training intervention and a maintenance period
Time frame: 0, 12 and 52 weeks
Change in inflammatory markers in urin, blood and adipose tissue following the diet or training intervention and a maintenance period
Time frame: 0, 12 and 52 weeks
Change in quality of life following the diet or training intervention and a maintenance period
Time frame: 0, 12 and 52 weeks
Change in ceramides, diacylglycerol og endocannabinoid (CB)-1 receptors in adipose tissue following the diet or training intervention and a maintenance period
Time frame: 0, 12 and 52 weeks
Change in hormones derived from adipose tissue following the diet or training intervention and a maintenance period
Time frame: 0, 12 and 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2014.
- Background: PubMed 24252596Pedersen 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.
- Background: PubMed 25082954Pedersen 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.
- Derived from this study: PubMed 31575375Pedersen 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.
- Derived from this study: PubMed 26803431Pedersen 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.
- Derived from this study: PubMed 26296452Pedersen 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.
- Derived from this study: PubMed 25802037Olsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Prescott, MD, DMsc principal investigator
Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interval Training and Weight Loss in people with Ischemic Heart Disease and Obesity, run by Eva Prescott at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Coronary Flow Reserve following the diet or training intervention and a maintenance period (time frame: 0, 12 and 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01724567, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2014.