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

August 3, 2014 updated by: Eva Prescott

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2400
        • Bispebjerg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
0, 12 and 52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Using the Endopat 2000 from Itamar
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
Assessed by echocardiography resting and during physiological and medical stress.
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
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).
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
Assessed by positron emission tomography of the heart
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
A Oral Glucose Tolerance Test is performed.
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
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
Assessed using a bicycle ergometer
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
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
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
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
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
0, 12 and 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eva Prescott

Collaborators

Rigshospitalet, Denmark
University of Copenhagen
University of California, Davis
University of Aarhus
Bispebjerg Hospital
Copenhagen University Hospital at Herlev
Texas A&M University
Amager Hospital
Copenhagen University Hospital, Hvidovre

Investigators

  • Principal Investigator: Eva Prescott, MD, DMsc, Bispebjerg Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

October 26, 2012

First Submitted That Met QC Criteria

November 7, 2012

First Posted (Estimate)

November 12, 2012

Study Record Updates

Last Update Posted (Estimate)

August 5, 2014

Last Update Submitted That Met QC Criteria

August 3, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CUT-IT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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