Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2026-03-01 @ 9:19 AM
Study NCT ID:
NCT02105805
Status:
COMPLETED
Last Update Posted:
2014-04-07
First Post:
2014-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Weight Loss as Treatment in Heart Disease
Sponsor:
University of Copenhagen
Organization:
Study Overview
Official Title:
Intentional Weight Loss as Treatment in Obese Patients With Ischaemic Heart Disease
Status:
COMPLETED
Status Verified Date:
2014-04
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:
None
Brief Summary:
30 obese moderate-to-severe heart failure patients will be randomized to intervention or control in groups of 5-10 subjects.
All will receive dietetic advice according to randomization and according to the European Heart Association.
Intervention subjects will initiate with 8 weeks low energy diet, 800-1000 kcal/d by formula diet and subsequent four weeks reintroduction to regular foods supplying 1200 kcal/d substituting two daily meals with formula meal replacement.
Control subjects are advised to follow the Nordic Nutrition Recommendations.
Patients will be monitored by blood sampling and assessed by change in physical performance.
All will receive dietetic advice according to randomization and according to the European Heart Association.
Intervention subjects will initiate with 8 weeks low energy diet, 800-1000 kcal/d by formula diet and subsequent four weeks reintroduction to regular foods supplying 1200 kcal/d substituting two daily meals with formula meal replacement.
Control subjects are advised to follow the Nordic Nutrition Recommendations.
Patients will be monitored by blood sampling and assessed by change in physical performance.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: