NCT01192373

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_2 heart-failure

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 1, 2010

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

January 21, 2013

Status Verified

January 1, 2013

Enrollment Period

6 months

First QC Date

August 24, 2010

Last Update Submit

January 18, 2013

Conditions

Heart FailureDiabetes

Outcome Measures

Primary Outcomes (3)

  • 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.

    1-6 weeks

  • 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.

    1-6 weeks

  • Exercise capacity and oxygen consumption

    Using treadmill and continues oxygen consumption measurement. Outcome is difference between low and high ciculating free fatty acids.

    1-6 weeks

Secondary Outcomes (3)

  • Regional left ventricular function

    1-6 weeks

  • 6 minutes hall walk test

    1-6 weeks

  • metabolic and hormonal profile

    1-6 weeks

Study Arms (2)

High circulating free fatty acids

EXPERIMENTAL

using Heparin af intralipid infusion for 8 hours

Other: Metabolic substrate modulation

Low circulation free fatty acids

ACTIVE COMPARATOR

using hyperinsulinaemic euglycemic clamp for 8 hours

Other: metabolic substrate modulation

Interventions

metabolic substrate modulationOTHER

for high circulation free fatty acids: Heparin (250IE/hour) + intralipid (20%, 62 ml/hour).

High circulating free fatty acids

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of cardiology, Aarhus University hospital Skejby,

Aarhus, Region Midjylland, 8200, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 23733915DERIVED

MeSH Terms

Conditions

Heart FailureDiabetes Mellitus

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Roni R Nielsen, MD

    Dept. of cardiolgy, Aarhus University hospital, Skejby. Brendstrupgaardsvej 100, 8200 Aarhus N, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2010

First Posted

September 1, 2010

Study Start

September 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2012

Last Updated

January 21, 2013

Record last verified: 2013-01

Locations

DK(1)