Understanding how diabetes affects heart function
Mitochondrial Substrate Utilization in the Diabetic Human Heart
This study looks at how diabetes affects heart function by testing heart tissue from patients with heart failure and type 2 diabetes to learn more about the connection between the two conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 20 Years to 85 Years |
| Sex | All |
| Sponsor | Heinrich-Heine University, Duesseldorf Academic / other |
| Locations | 1 site (Düsseldorf) |
| Trial ID | NCT05958706 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the differences in mitochondrial substrate utilization and complex activity in the hearts of patients with heart failure and type 2 diabetes mellitus (T2DM). It will analyze myocardial mitochondrial oxidative function, metabolic parameters, gene expression, and inflammation in cardiac tissue from patients undergoing heart transplantation or with heart failure. Cardiac function will be assessed using advanced imaging techniques, including cardiac magnetic resonance imaging and spectroscopy, alongside oral glucose tolerance tests to characterize glycemic control. The findings are expected to enhance our understanding of diabetic cardiomyopathy and its underlying mechanisms.
Who should consider this trial
Good fit: Ideal candidates include adults aged 20 to 85 with heart failure and a clinical indication for myocardial biopsy, with or without type 2 diabetes.
Not a fit: Patients with acute infectious diseases, autoimmune diseases, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic methods and treatments for diabetic cardiomyopathy.
How similar studies have performed: Previous studies have indicated mitochondrial dysfunction in diabetes, suggesting that this approach may yield valuable insights, although the specific methodology here is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 20 and ≤ 85 years * Male and female patients with manifest heart failure (NYHA II-IV) and clinical indication for myocardial biopsy or after transplantation and clinical indication for myocardial biopsy with or without type II diabetes mellitus or terminal (NYHA IV) heart failure with or without type II diabetes mellitus. * Written informed consent Exclusion Criteria: * Acute infectious diseases within the last 2 weeks before the examination * Autoimmune diseases or acute immunocompromising diseases (leukocytes \< 5000/μl) * Pregnancy * Use of alcohol or drugs (addiction), psychiatric diseases * Suspected or manifest AIDS (HIV); hepatitis B or C. * Liver disease not attributed to the presence of nonalcoholic fatty liver hepatitis or congestive hepatopathy in heart failure * Malignant cancer * Lack of capacity to give informed consent or lack of consent to participate in the study * For MRI study with drug stress: contraindications to the use of regadenoson, specifically: a) Hypersensitivity to the active ingredient or any of the other ingredients mentioned. b) Second- or third-degree atrioventricular (AV) block or sinus node dysfunction, unless these patients have a functioning pacemaker. c) Unstable angina that has not been stabilized with medication. d) Severe hypotension. e) Decompensated stages of heart failure.
Where this trial is running
Düsseldorf
- University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine — Düsseldorf, Germany (Recruiting)
Study contacts
- Principal investigator: Elric Zweck, MD — Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf
- Study coordinator: Elric Zweck, MD
- Email: elric.zweck@med.uni-duesseldorf.de
- Phone: +492118118800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.