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Modulation of Free Fatty Acids in Heart Failure Patients With Diabetes: "Effect on Left Ventricular Function" (Metamod3)

Primary Purpose

Heart Failure, Diabetes

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Metabolic substrate modulation
metabolic substrate modulation
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ejection fraction at or lower than 45%
  • type 2 diabetes

Exclusion Criteria:

  • known s-creatinine >220mM
  • known S-alanine aminotransferase >3 times normal upper limit
  • other disabilitating conditions
  • pregnancy
  • insulin treatment

Sites / Locations

  • Dept. of cardiology, Aarhus University hospital Skejby,

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High circulating free fatty acids

Low circulation free fatty acids

Arm Description

using Heparin af intralipid infusion for 8 hours

using hyperinsulinaemic euglycemic clamp for 8 hours

Outcomes

Primary Outcome Measures

Left ventricular function
Left ventricular systolic function (Ejection fraction, tissue velocity, Strain and strain rate). Left ventricular diastolic funtion (E/A ratio, E/e' ratio, IVRT) Cardiac output. All parameters measured at rest and peak exercise and outcome is difference between low and high ciculating free fatty acids.
intracellular lipid content
Magnetic Resonans proton spectroscopy (septal myocardial intracellular lipid content) Magnetic Resonans proton spectroscopy (Tibialis anterior muscle intracellular lipid content). Outcome is difference between low and high ciculating free fatty acids.
Exercise capacity and oxygen consumption
Using treadmill and continues oxygen consumption measurement. Outcome is difference between low and high ciculating free fatty acids.

Secondary Outcome Measures

Regional left ventricular function
regional speckle tracking during rest and peak exercise. Outcome is difference between low and high ciculating free fatty acids.
6 minutes hall walk test
distance difference between low and high levels of circulating FFA. Outcome is difference between low and high ciculating free fatty acids.
metabolic and hormonal profile
bloodsamples

Full Information

First Posted
August 24, 2010
Last Updated
January 18, 2013
Sponsor
University of Aarhus
Collaborators
Danish Heart Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01192373
Brief Title
Modulation of Free Fatty Acids in Heart Failure Patients With Diabetes: "Effect on Left Ventricular Function"
Acronym
Metamod3
Official Title
Short Term Modulation of Circulating Free Fatty Acids in Heart Failure Patients With Type 2 Diabetes: "Effect on Myocardial Lipid Content, Left Ventricular Function and Exercise Capacity"
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Danish Heart Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators wish to investigate the the short term effect of low circulating free fatty acids in congestive heart failure patients with type 2 diabetes. Hypothesis: Low levels of circulating free fatty acids decrease myocardial and peripheral muscle lipid content, improves cardiac performance and exercise capacity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High circulating free fatty acids
Arm Type
Experimental
Arm Description
using Heparin af intralipid infusion for 8 hours
Arm Title
Low circulation free fatty acids
Arm Type
Active Comparator
Arm Description
using hyperinsulinaemic euglycemic clamp for 8 hours
Intervention Type
Other
Intervention Name(s)
Metabolic substrate modulation
Intervention Description
for high circulation free fatty acids: Heparin (250IE/hour) + intralipid (20%, 62 ml/hour).
Intervention Type
Other
Intervention Name(s)
metabolic substrate modulation
Intervention Description
low circulating free acids: hyperinsulinaemic euglycemic clamp (0,8 mUkg/min) with venous blood glucose at 4,5-6,5 mM.
Primary Outcome Measure Information:
Title
Left ventricular function
Description
Left ventricular systolic function (Ejection fraction, tissue velocity, Strain and strain rate). Left ventricular diastolic funtion (E/A ratio, E/e' ratio, IVRT) Cardiac output. All parameters measured at rest and peak exercise and outcome is difference between low and high ciculating free fatty acids.
Time Frame
1-6 weeks
Title
intracellular lipid content
Description
Magnetic Resonans proton spectroscopy (septal myocardial intracellular lipid content) Magnetic Resonans proton spectroscopy (Tibialis anterior muscle intracellular lipid content). Outcome is difference between low and high ciculating free fatty acids.
Time Frame
1-6 weeks
Title
Exercise capacity and oxygen consumption
Description
Using treadmill and continues oxygen consumption measurement. Outcome is difference between low and high ciculating free fatty acids.
Time Frame
1-6 weeks
Secondary Outcome Measure Information:
Title
Regional left ventricular function
Description
regional speckle tracking during rest and peak exercise. Outcome is difference between low and high ciculating free fatty acids.
Time Frame
1-6 weeks
Title
6 minutes hall walk test
Description
distance difference between low and high levels of circulating FFA. Outcome is difference between low and high ciculating free fatty acids.
Time Frame
1-6 weeks
Title
metabolic and hormonal profile
Description
bloodsamples
Time Frame
1-6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ejection fraction at or lower than 45% type 2 diabetes Exclusion Criteria: known s-creatinine >220mM known S-alanine aminotransferase >3 times normal upper limit other disabilitating conditions pregnancy insulin treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roni R Nielsen, MD
Organizational Affiliation
Dept. of cardiolgy, Aarhus University hospital, Skejby. Brendstrupgaardsvej 100, 8200 Aarhus N, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of cardiology, Aarhus University hospital Skejby,
City
Aarhus
State/Province
Region Midjylland
ZIP/Postal Code
8200
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
23733915
Citation
Nielsen R, Norrelund H, Kampmann U, Kim WY, Ringgaard S, Schar M, Moller N, Botker HE, Wiggers H. Failing heart of patients with type 2 diabetes mellitus can adapt to extreme short-term increases in circulating lipids and does not display features of acute myocardial lipotoxicity. Circ Heart Fail. 2013 Jul;6(4):845-52. doi: 10.1161/CIRCHEARTFAILURE.113.000187. Epub 2013 Jun 3.
Results Reference
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Modulation of Free Fatty Acids in Heart Failure Patients With Diabetes: "Effect on Left Ventricular Function"

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