Metabolic Determinants of Cardiac Function
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|ClinicalTrials.gov 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
|Condition or disease|
|Heart Failure Diabetes Mellitus|
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.
|Study Type :||Observational|
|Estimated Enrollment :||110 participants|
|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|
|Type 2 Diabetes|
- mitochondrial oxygen flux [ Time Frame: Up to 36 months ]measured using high resolution respirometry. Unit: pmol/(s*mg)
Biospecimen Retention: Samples Without DNA
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 ClinicalTrials.gov identifier (NCT number): NCT03386864
|Contact: Julia Szendroedi, PD Dr. med, PhDfirstname.lastname@example.org|
|Contact: Ralf Westenfeld, PD Dr. email@example.com|
|German Diabetes Center||Recruiting|
|Düsseldorf, NRW, Germany, 40223|
|Contact: Julia Szendroedi, PD Dr. med., PhD +492113382203 Julia.firstname.lastname@example.org|
|Sub-Investigator: Daniel Scheiber, Dr. med|