Investigating how gene regulation affects energy metabolism in obese cardiac surgery patients
An Observational Case Control Study to Identify the Role of Epigenetic Regulation of Genes Responsible for Energy Metabolism and Mitochondrial Function in the Obesity Paradox in Cardiac Surgery
This study is trying to see how gene changes affect energy use in obese patients having heart surgery compared to those who aren't obese.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | University of Leicester Academic / other |
| Locations | 1 site (Glenfield, Leicestershire) |
| Trial ID | NCT02908009 on ClinicalTrials.gov |
What this trial studies
This observational study compares the expression of genes related to energy utilization and mitochondrial function in obese and non-obese adult patients undergoing cardiac surgery. It focuses on understanding the epigenetic regulation of these genes and their role in the obesity paradox, particularly in patients undergoing coronary artery bypass grafting. By analyzing histone acetylation and DNA methylation levels, the study aims to uncover potential differences in metabolic responses between the two groups. The research is conducted at a single center in England and involves a prospective case-control design.
Who should consider this trial
Good fit: Ideal candidates are adult patients with pre-existing atrial fibrillation who are scheduled for cardiac surgery.
Not a fit: Patients with acute inflammatory states, severe heart failure, or those requiring emergency procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of cardiac surgery outcomes in obese patients.
How similar studies have performed: While the specific approach of this study may be novel, similar studies have explored the relationship between obesity and cardiac surgery outcomes, indicating potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with pre-existing paroxysmal, persistent or chronic atrial fibrillation, Exclusion Criteria: * Patients with pre-existing inflammatory state: sepsis undergoing treatment, acute kidney injury within 5 days, chronic inflammatory disease, congestive heart failure. * Emergency or salvage procedure. * Ejection fraction \<30 %. * Patient in a critical preoperative state (Kidney Disease: Improving Global Outcomes (KDIGO) Stage 3 AKI \[20\] or requiring inotropes, ventilation or intra-aortic balloon pump). * Pregnancy.
Where this trial is running
Glenfield, Leicestershire
- England — Glenfield, Leicestershire, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Gavin Murphy — University of Leicester
- Study coordinator: Tracy Kumar
- Email: tk98@leicester.ac.uk
- Phone: 01162583039
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.