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

3. august 2014 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

70

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Danmark
      • Copenhagen, Danmark, 2400
        • Bispebjerg Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

45 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: Weight Loss
Low calorie diet approx. 1000 kcal/day for 8 - 10 weeks to obtain a 10 - 15 % weight loss.
Eksperimentel: Interval Training
12 weeks of interval training 3 times a week followed by 40 weeks of interval training 2 times a week.
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Coronary Flow Reserve following the diet or training intervention and a maintenance period
Tidsramme: 0, 12 and 52 weeks
Assessed by a non-invasive echocardiographic Doppler measurement
0, 12 and 52 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Heart Rate Variability and silent ischemia following the diet or training intervention and a maintenance period
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 0, 12 and 52 weeks
0, 12 and 52 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Eva Prescott

Samarbejdspartnere

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

Efterforskere

  • Ledende efterforsker: Eva Prescott, MD, DMsc, Bispebjerg Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2011

Primær færdiggørelse (Faktiske)

1. april 2014

Studieafslutning (Faktiske)

1. april 2014

Datoer for studieregistrering

Først indsendt

26. oktober 2012

Først indsendt, der opfyldte QC-kriterier

7. november 2012

Først opslået (Skøn)

12. november 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

5. august 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. august 2014

Sidst verificeret

1. august 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CUT-IT

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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