Weight Loss as Treatment in Heart Disease

April 2, 2014 updated by: Arne Astrup, University of Copenhagen

Intentional Weight Loss as Treatment in Obese Patients With Ischaemic Heart Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in six minute walk test from baseline to week 16 (end of study)
Time Frame: weeks 0 and 16
Performance measure
weeks 0 and 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
weeks 0,1,2,4,6,8,10,12,14,16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

University Hospital, Gentofte, Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

March 28, 2014

First Submitted That Met QC Criteria

April 2, 2014

First Posted (Estimate)

April 7, 2014

Study Record Updates

Last Update Posted (Estimate)

April 7, 2014

Last Update Submitted That Met QC Criteria

April 2, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEN-01-clinnutr

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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