Copenhagen Study of Obese Patients With Ischemic Heart Disease Undergoing Low Energy Diet or Interval Training (CUT-IT)
3 août 2014 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
70
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
-
Copenhagen, Danemark, 2400
- Bispebjerg Hospital
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
45 ans à 75 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La 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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
Low calorie diet approx.
1000 kcal/day for 8 - 10 weeks to obtain a 10 - 15 % weight loss.
|
|
Expérimental: Interval Training
12 weeks of interval training 3 times a week followed by 40 weeks of interval training 2 times a week.
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Coronary Flow Reserve following the diet or training intervention and a maintenance period
Délai: 0, 12 and 52 weeks
|
Assessed by a non-invasive echocardiographic Doppler measurement
|
0, 12 and 52 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Heart Rate Variability and silent ischemia following the diet or training intervention and a maintenance period
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 0, 12 and 52 weeks
|
0, 12 and 52 weeks
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Eva Prescott, MD, DMsc, Bispebjerg Hospital
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Pedersen LR, Olsen RH, Frederiksen M, Astrup A, Chabanova E, Hasbak P, Holst JJ, Kjaer A, Newman JW, Walzem R, Wisloff 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.
- Pedersen LR, Olsen RH, Jurs A, Astrup A, Chabanova E, Simonsen L, Wisloff 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.
- Pedersen LR, Olsen RH, Anholm C, Astrup A, Eugen-Olsen J, Fenger M, Simonsen L, Walzem RL, Haugaard SB, Prescott E. Effects of 1 year of exercise training versus combined exercise training and weight loss on body composition, low-grade inflammation and lipids in overweight patients with coronary artery disease: a randomized trial. Cardiovasc Diabetol. 2019 Oct 1;18(1):127. doi: 10.1186/s12933-019-0934-x.
- Pedersen LR, Olsen RH, Anholm C, Walzem RL, Fenger M, Eugen-Olsen J, Haugaard SB, Prescott E. Weight loss is superior to exercise in improving the atherogenic lipid profile in a sedentary, overweight population with stable coronary artery disease: A randomized trial. Atherosclerosis. 2016 Mar;246:221-8. doi: 10.1016/j.atherosclerosis.2016.01.001. Epub 2016 Jan 13.
- Pedersen LR, Olsen RH, Jurs A, Anholm C, Fenger M, Haugaard SB, Prescott E. A randomized trial comparing the effect of weight loss and exercise training on insulin sensitivity and glucose metabolism in coronary artery disease. Metabolism. 2015 Oct;64(10):1298-307. doi: 10.1016/j.metabol.2015.07.007. Epub 2015 Jul 17.
- Olsen RH, Pedersen LR, Jurs A, Snoer M, Haugaard SB, Prescott E. A randomised trial comparing the effect of exercise training and weight loss on microvascular function in coronary artery disease. Int J Cardiol. 2015 Apr 15;185:229-35. doi: 10.1016/j.ijcard.2015.03.118. Epub 2015 Mar 11.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 septembre 2011
Achèvement primaire (Réel)
1 avril 2014
Achèvement de l'étude (Réel)
1 avril 2014
Dates d'inscription aux études
Première soumission
26 octobre 2012
Première soumission répondant aux critères de contrôle qualité
7 novembre 2012
Première publication (Estimation)
12 novembre 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
5 août 2014
Dernière mise à jour soumise répondant aux critères de contrôle qualité
3 août 2014
Dernière vérification
1 août 2014
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CUT-IT
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .