<?xml version="1.0" encoding="UTF-8"?>
<clinical_study rank="69772">
<!-- This xml conforms to an XML Schema at:
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<required_header>
<download_date>ClinicalTrials.gov processed this data on December 16, 2015</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/show/NCT01724567</url>
</required_header>
<id_info>
<org_study_id>CUT-IT</org_study_id>
<nct_id>NCT01724567</nct_id>
</id_info>
<brief_title>Copenhagen Study of Obese Patients With Ischemic Heart Disease Undergoing Low Energy Diet or Interval Training</brief_title>
<acronym>CUT-IT</acronym>
<official_title>Copenhagen Study of Obese Patients With Ischemic Heart Disease Undergoing Low Energy Diet or Interval Training: A Randomized Clinical Trial</official_title>
<sponsors>
<lead_sponsor>
<agency>Eva Prescott</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>University of Copenhagen</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Amager Hospital</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Bispebjerg Hospital</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Copenhagen University Hospital at Herlev</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Copenhagen University Hospital, Hvidovre</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Rigshospitalet, Denmark</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>University of California, Davis</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Texas A&M University</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>University of Aarhus</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Bispebjerg Hospital</source>
<oversight_info>
<authority>Denmark: The Danish National Committee on Biomedical Research Ethics</authority>
<authority>Denmark: Danish Dataprotection Agency</authority>
<has_dmc>No</has_dmc>
</oversight_info>
<brief_summary>
<textblock>
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.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
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.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>September 2011</start_date>
<completion_date type="Actual">April 2014</completion_date>
<primary_completion_date type="Actual">April 2014</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<study_design>Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention</study_design>
<primary_outcome>
<measure>Change in Coronary Flow Reserve following the diet or training intervention and a maintenance period</measure>
<time_frame>0, 12 and 52 weeks</time_frame>
<safety_issue>No</safety_issue>
<description>Assessed by a non-invasive echocardiographic Doppler measurement</description>
</primary_outcome>
<secondary_outcome>
<measure>Change in Heart Rate Variability and silent ischemia following the diet or training intervention and a maintenance period</measure>
<time_frame>0, 12 and 52 weeks</time_frame>
<safety_issue>No</safety_issue>
<description>Assessed by Holter Monitoring for 24 - 48 hours</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in endothelial function following the diet or training intervention and a maintenance period</measure>
<time_frame>0, 12 and 52 weeks</time_frame>
<safety_issue>No</safety_issue>
<description>Using the Endopat 2000 from Itamar</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in systolic and diastolic function following the diet or training intervention and a maintenance period</measure>
<time_frame>0, 12 and 52 weeks</time_frame>
<safety_issue>No</safety_issue>
<description>Assessed by echocardiography resting and during physiological and medical stress.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in body composition following the diet or training intervention and a maintenance period</measure>
<time_frame>0, 12 and 52 weeks</time_frame>
<safety_issue>No</safety_issue>
<description>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).</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in myocardial blood flow following the diet or training intervention and a maintenance period</measure>
<time_frame>0, 12 and 52 weeks</time_frame>
<safety_issue>No</safety_issue>
<description>Assessed by positron emission tomography of the heart</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in insulin action, beta cell function and incretin secretion following the diet or training intervention and a maintenance period</measure>
<time_frame>0, 12 and 52 weeks</time_frame>
<safety_issue>No</safety_issue>
<description>A Oral Glucose Tolerance Test is performed.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in oxidized lipids and lipoprotein particle size following the diet or training intervention and a maintenance period</measure>
<time_frame>0, 12 and 52 weeks</time_frame>
<safety_issue>No</safety_issue>
</secondary_outcome>
<secondary_outcome>
<measure>Change in peak oxygen uptake (VO2max) following the diet or training intervention and a maintenance period</measure>
<time_frame>0, 12 and 52 weeks</time_frame>
<safety_issue>No</safety_issue>
<description>Assessed using a bicycle ergometer</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in blood pressure following the diet or training intervention and a maintenance period</measure>
<time_frame>0, 12 and 52 weeks</time_frame>
<safety_issue>No</safety_issue>
</secondary_outcome>
<secondary_outcome>
<measure>Change in inflammatory markers in urin, blood and adipose tissue following the diet or training intervention and a maintenance period</measure>
<time_frame>0, 12 and 52 weeks</time_frame>
<safety_issue>No</safety_issue>
</secondary_outcome>
<secondary_outcome>
<measure>Change in quality of life following the diet or training intervention and a maintenance period</measure>
<time_frame>0, 12 and 52 weeks</time_frame>
<safety_issue>No</safety_issue>
</secondary_outcome>
<secondary_outcome>
<measure>Change in ceramides, diacylglycerol og endocannabinoid (CB)-1 receptors in adipose tissue following the diet or training intervention and a maintenance period</measure>
<time_frame>0, 12 and 52 weeks</time_frame>
<safety_issue>No</safety_issue>
</secondary_outcome>
<secondary_outcome>
<measure>Change in hormones derived from adipose tissue following the diet or training intervention and a maintenance period</measure>
<time_frame>0, 12 and 52 weeks</time_frame>
<safety_issue>No</safety_issue>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">70</enrollment>
<condition>Ischemic Heart Disease</condition>
<condition>Obesity</condition>
<arm_group>
<arm_group_label>Weight Loss</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>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.</description>
</arm_group>
<arm_group>
<arm_group_label>Interval Training</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>12 weeks of interval training 3 times a week followed by 40 weeks of interval training 2 times a week.</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Interval Training</intervention_name>
<description>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.</description>
<arm_group_label>Interval Training</arm_group_label>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Weight Loss</intervention_name>
<description>Low calorie diet approx. 1000 kcal/day for 8 - 10 weeks to obtain a 10 - 15 % weight loss.</description>
<arm_group_label>Weight Loss</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
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
</textblock>
</criteria>
<gender>Both</gender>
<minimum_age>45 Years</minimum_age>
<maximum_age>75 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Eva Prescott, MD, DMsc</last_name>
<role>Principal Investigator</role>
<affiliation>Bispebjerg Hospital</affiliation>
</overall_official>
<location>
<facility>
<name>Bispebjerg Hospital</name>
<address>
<city>Copenhagen</city>
<zip>2400</zip>
<country>Denmark</country>
</address>
</facility>
</location>
<location_countries>
<country>Denmark</country>
</location_countries>
<reference>
<citation>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.</citation>
<PMID>24252596</PMID>
</reference>
<reference>
<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.</citation>
<PMID>25082954</PMID>
</reference>
<verification_date>August 2014</verification_date>
<lastchanged_date>August 3, 2014</lastchanged_date>
<firstreceived_date>October 26, 2012</firstreceived_date>
<responsible_party>
<responsible_party_type>Sponsor-Investigator</responsible_party_type>
<investigator_affiliation>Bispebjerg Hospital</investigator_affiliation>
<investigator_full_name>Eva Prescott</investigator_full_name>
<investigator_title>MD, MDsc</investigator_title>
</responsible_party>
<keyword>Interval Training</keyword>
<keyword>Weight Loss</keyword>
<keyword>Secondary Prevention</keyword>
<keyword>Rehabilitation</keyword>
<keyword>Cardiovascular Risk Factors</keyword>
<is_fda_regulated>No</is_fda_regulated>
<has_expanded_access>No</has_expanded_access>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Coronary Artery Disease</mesh_term>
<mesh_term>Heart Diseases</mesh_term>
<mesh_term>Ischemia</mesh_term>
<mesh_term>Myocardial Ischemia</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
