Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-02-25 @ 5:49 PM
Study NCT ID:
NCT01724567
Status:
COMPLETED
Last Update Posted:
2014-08-05
First Post:
2012-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Copenhagen Study of Obese Patients With Ischemic Heart Disease Undergoing Low Energy Diet or Interval Training
Sponsor:
Eva Prescott
Organization:
Study Overview
Official Title:
Copenhagen Study of Obese Patients With Ischemic Heart Disease Undergoing Low Energy Diet or Interval Training: A Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2014-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CUT-IT
Brief Summary:
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: