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Metabolic Determinants of Cardiac Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03386864
Recruitment Status : Unknown
Verified December 2017 by julia szendrödi, German Diabetes Center.
Recruitment status was:  Recruiting
First Posted : December 29, 2017
Last Update Posted : December 29, 2017
Heinrich-Heine University, Duesseldorf
Information provided by (Responsible Party):
julia szendrödi, German Diabetes Center

Brief Summary:
Assessment of cardiac energy metabolism in patients with impaired glucose tolerance

Condition or disease
Heart Failure Diabetes Mellitus

Detailed Description:

Insulin resistance, hepatocellular lipids (HCL) and plasma concentrations of free fatty acids (FFA) are predictors of heart failure, the leading cause of mortality in patients suffering from type 2 diabetes mellitus (T2DM). Epidemiological data suggest that diabetic cardiomyopathy (DC) presents as ventricular dysfunction in patients with T2DM independent of coronary artery disease. The underlying cellular mechanisms are poorly understood. Reduced mitochondrial activity and insulin resistance of skeletal muscle relates to liver steatosis, possibly due to higher substrate flux to the liver. High oxidation rates in the liver result in oxidative stress, damage of mitochondria and apoptosis. The investigators hypothesize that (i) HCL and impaired liver energy metabolism correlate with ventricular dysfunction, (ii) impaired glucose uptake and mitochondrial capacity in skeletal muscle relates to enhanced oxidative capacity, oxidative stress and lipid deposition in heart tissue (iii) reduced myocardial oxidative capacity limits recovery of myocardial function in patients with acute heart failure.

The investigators aim to assess (i) liver energy metabolism and heart function, (ii) respiration and lipid metabolites in skeletal muscle and heart tissue in humans with advanced heart failure and (iii) the prognostic impact of these factors in humans with acute heart failure.

This study will improve the understanding of mechanisms underlying the development of DC and the identification of patients at risk for poor outcome in heart failure.

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Study Type : Observational
Estimated Enrollment : 110 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Metabolic Determinants of Cardiac Function
Actual Study Start Date : April 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Insulin Resistant
Type 2 Diabetes

Primary Outcome Measures :
  1. mitochondrial oxygen flux [ Time Frame: Up to 36 months ]
    measured using high resolution respirometry. Unit: pmol/(s*mg)

Biospecimen Retention:   Samples Without DNA
Myocardial biopsies blood samples

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients undergoing myocardial biopsy, left ventricular assist device implantation or heart transplantation for medical reasons

Inclusion Criteria:

  • age ≥ 20 and ≤85 years
  • myocardial biopsy for medical reason

Exclusion Criteria:

  • acute infection
  • autoimmune disease
  • pregnancy
  • cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03386864

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Contact: Julia Szendroedi, PD Dr. med, PhD +492113382203
Contact: Ralf Westenfeld, PD Dr. med +4921118800

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German Diabetes Center Recruiting
Düsseldorf, NRW, Germany, 40223
Contact: Julia Szendroedi, PD Dr. med., PhD    +492113382203   
Sub-Investigator: Daniel Scheiber, Dr. med         
Sponsors and Collaborators
German Diabetes Center
Heinrich-Heine University, Duesseldorf

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: julia szendrödi, PD Dr. med. Julia Szendroedi, PhD, German Diabetes Center Identifier: NCT03386864    
Other Study ID Numbers: 5263R
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: December 29, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by julia szendrödi, German Diabetes Center:
Heart Failure, Diabetes Mellitus, Mitochondrial Respiration
Additional relevant MeSH terms:
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Heart Failure
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases