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Weight Loss as Treatment in Heart Disease

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ClinicalTrials.gov Identifier: NCT02105805
Recruitment Status : Completed
First Posted : April 7, 2014
Last Update Posted : April 7, 2014
Sponsor:
Collaborator:
University Hospital, Gentofte, Copenhagen
Information provided by (Responsible Party):
Arne Astrup, University of Copenhagen

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.


Condition or disease Intervention/treatment Phase
Heart Failure Behavioral: Dietetic group sessions Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intentional Weight Loss as Treatment in Obese Patients With Ischaemic Heart Disease
Study Start Date : October 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: low energy diet
low energy diet treatment
Behavioral: Dietetic group sessions
Group sessions to improve dietary adherence

Active Comparator: Nordic recommendation
Nordic recommendation, no restrictions on energy
Behavioral: Dietetic group sessions
Group sessions to improve dietary adherence




Primary Outcome Measures :
  1. Change in six minute walk test from baseline to week 16 (end of study) [ Time Frame: weeks 0 and 16 ]
    Performance measure


Secondary Outcome Measures :
  1. Change in lipid status from baseline to week 16 (end of study). [ Time Frame: weeks 0,1,2,4,6,8,10,12,14,16 ]
    Blood sample and analyses for lipids



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • bmi >30
  • heart failure, moderate to severe, new york heart association II og III
  • stable disease
  • age >18 years
  • out-patients
  • perform a six minutes walk test
  • given consent

Exclusion Criteria:

  • unstable disease
  • insulin treated diabetes
  • pregnancy or lactating
  • unstable weight past 6 months (+- 10 kg)
  • planned procedures in the time of intervention

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Responsible Party: Arne Astrup, Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT02105805     History of Changes
Other Study ID Numbers: GEN-01-clinnutr
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: April 7, 2014
Last Verified: April 2014
Keywords provided by Arne Astrup, University of Copenhagen:
intention weight loss
heart failure
6-minute walk test
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Weight Loss
Cardiovascular Diseases
Body Weight Changes
Body Weight
Signs and Symptoms