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Completed

NCT Number: NCT01724567

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

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.

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Key information

Conditions

Ischemic Heart Disease Body Weight Body Weight Changes Cardiovascular Diseases Heart Diseases Myocardial Ischemia Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases Weight Loss

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bispebjerg Hospital

Copenhagen, 2400, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interval training

Other

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

Other

Low calorie diet approx. 1000 kcal/day for 8 - 10 weeks to obtain a 10 - 15 % weight loss.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    Assessed by Holter Monitoring for 24 - 48 hours

  2. Change in endothelial function following the diet or training intervention and a maintenance period

    Time frame: 0, 12 and 52 weeks

    Using the Endopat 2000 from Itamar

  3. Change in systolic and diastolic function following the diet or training intervention and a maintenance period

    Time frame: 0, 12 and 52 weeks

    Assessed by echocardiography resting and during physiological and medical stress.

  4. Change in body composition following the diet or training intervention and a maintenance period

    Time frame: 0, 12 and 52 weeks

    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).

  5. Change in myocardial blood flow following the diet or training intervention and a maintenance period

    Time frame: 0, 12 and 52 weeks

    Assessed by positron emission tomography of the heart

  6. 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

    A Oral Glucose Tolerance Test is performed.

  7. 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

  8. Change in peak oxygen uptake (VO2max) following the diet or training intervention and a maintenance period

    Time frame: 0, 12 and 52 weeks

    Assessed using a bicycle ergometer

  9. Change in blood pressure following the diet or training intervention and a maintenance period

    Time frame: 0, 12 and 52 weeks

  10. 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

  11. Change in quality of life following the diet or training intervention and a maintenance period

    Time frame: 0, 12 and 52 weeks

  12. 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

  13. Change in hormones derived from adipose tissue following the diet or training intervention and a maintenance period

    Time frame: 0, 12 and 52 weeks

Sponsors and collaborators

Lead sponsor

Eva Prescott

Other

Collaborators

  • 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

Registry information

Official study title

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

Acronym: CUT-IT

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Nov 12, 2012
Registry last updated
Aug 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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