Copenhagen Study of Obese Patients With Ischemic Heart Disease Undergoing Low Energy Diet or Interval Training (CUT-IT)

This study has been completed.
Sponsor:
Collaborators:
University of Copenhagen
Amager Hospital
Bispebjerg Hospital
Copenhagen University Hospital at Herlev
Copenhagen University Hospital, Hvidovre
Rigshospitalet, Denmark
University of California, Davis
Texas A&M University
University of Aarhus
Information provided by (Responsible Party):
Eva Prescott, Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT01724567
First received: October 26, 2012
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Ischemic Heart Disease
Obesity
Other: Interval Training
Other: Weight Loss

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Copenhagen Study of Obese Patients With Ischemic Heart Disease Undergoing Low Energy Diet or Interval Training: A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • Change in Coronary Flow Reserve following the diet or training intervention and a maintenance period [ Time Frame: 0, 12 and 52 weeks ] [ Designated as safety issue: No ]
    Assessed by a non-invasive echocardiographic Doppler measurement


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Assessed by Holter Monitoring for 24 - 48 hours

  • Change in endothelial function following the diet or training intervention and a maintenance period [ Time Frame: 0, 12 and 52 weeks ] [ Designated as safety issue: No ]
    Using the Endopat 2000 from Itamar

  • Change in systolic and diastolic function following the diet or training intervention and a maintenance period [ Time Frame: 0, 12 and 52 weeks ] [ Designated as safety issue: No ]
    Assessed by echocardiography resting and during physiological and medical stress.

  • Change in body composition following the diet or training intervention and a maintenance period [ Time Frame: 0, 12 and 52 weeks ] [ Designated as safety issue: No ]
    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).

  • Change in myocardial blood flow following the diet or training intervention and a maintenance period [ Time Frame: 0, 12 and 52 weeks ] [ Designated as safety issue: No ]
    Assessed by positron emission tomography of the heart

  • 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 ] [ Designated as safety issue: No ]
    A Oral Glucose Tolerance Test is performed.

  • 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 ] [ Designated as safety issue: No ]
  • Change in peak oxygen uptake (VO2max) following the diet or training intervention and a maintenance period [ Time Frame: 0, 12 and 52 weeks ] [ Designated as safety issue: No ]
    Assessed using a bicycle ergometer

  • Change in blood pressure following the diet or training intervention and a maintenance period [ Time Frame: 0, 12 and 52 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change in quality of life following the diet or training intervention and a maintenance period [ Time Frame: 0, 12 and 52 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change in hormones derived from adipose tissue following the diet or training intervention and a maintenance period [ Time Frame: 0, 12 and 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: September 2011
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Weight Loss
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.
Other: Weight Loss
Low calorie diet approx. 1000 kcal/day for 8 - 10 weeks to obtain a 10 - 15 % weight loss.
Experimental: Interval Training
12 weeks of interval training 3 times a week followed by 40 weeks of interval training 2 times a week.
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.

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

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01724567

Locations
Denmark
Bispebjerg Hospital
Copenhagen, Denmark, 2400
Sponsors and Collaborators
Eva Prescott
University of Copenhagen
Amager Hospital
Bispebjerg Hospital
Copenhagen University Hospital at Herlev
Copenhagen University Hospital, Hvidovre
Rigshospitalet, Denmark
University of California, Davis
Texas A&M University
University of Aarhus
Investigators
Principal Investigator: Eva Prescott, MD, DMsc Bispebjerg Hospital
  More Information

Publications:
Responsible Party: Eva Prescott, MD, MDsc, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT01724567     History of Changes
Other Study ID Numbers: CUT-IT
Study First Received: October 26, 2012
Last Updated: April 7, 2014
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Bispebjerg Hospital:
Interval Training
Weight Loss
Secondary Prevention
Rehabilitation
Cardiovascular Risk Factors

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Ischemia
Obesity
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 26, 2014