Using brief arm cuff cycles to protect the heart during bypass surgery for people with type 2 diabetes
Official title: The Effect of Remote Ischemic Preconditioning on Myocardial Protection in Patients With Type 2 Diabetes Mellitus Undergoing Coronary Artery Bypass Graft Surgery: A Randomized Controlled Double-Blind Study
Run by Muğla Sıtkı Koçman University · NCT06977230 · Data updated 2026-11-12
This study will test whether brief cycles of arm cuff inflation before elective CABG can reduce heart muscle injury in people with type 2 diabetes.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 45 Years to 85 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Muğla Sıtkı Koçman University Academic / other |
| Locations | 2 sites (Muğla and 1 other locations) |
| Status | Recruiting |
| Started | May 26, 2025 |
| Main results expected | July 30, 2025 |
| Study ends | September 15, 2025 |
| Registry record updated | June 18, 2025 |
| Trial ID | NCT06977230 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 40–85 with type 2 diabetes on medical treatment who are scheduled for isolated elective CABG and classified ASA III–IV are the intended candidates.
✕Probably not a fit
Patients needing emergency or repeat CABG, with LVEF under 40%, significant upper-limb peripheral arterial disease, severe renal or hepatic failure, pregnancy, asthma, or taking glibenclamide or nicorandil are excluded and unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, double-blind, prospective trial enrolling 60 patients aged 40–85 with medically treated type 2 diabetes undergoing isolated elective coronary artery bypass grafting. Participants are randomized to receive remote ischemic preconditioning (five cycles of upper-limb cuff inflation and deflation before sternotomy) or standard care with blinding maintained. The primary outcome is perioperative myocardial injury measured by high-sensitivity troponin T at 24, 48, and 72 hours after surgery. Secondary outcomes include acute kidney injury by KDIGO criteria and other perioperative complications.
Why it matters
Potential benefit: If effective, the intervention could reduce heart muscle damage during surgery and potentially lower post‑operative complications and recovery time.
How similar studies have gone: Prior trials of remote ischemic conditioning in cardiac surgery have shown mixed results—some reductions in biomarkers but inconsistent clinical benefit—and effectiveness specifically in people with diabetes is not well established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed with type 2 diabetes mellitus and receiving medical treatment * Scheduled for isolated elective coronary artery bypass graft (CABG) surgery * American Society of Anesthesiologists (ASA) physical status class III or IV * Age between 40 and 85 years Exclusion Criteria: Emergency CABG surgery Reoperation (revision surgery) Left ventricular ejection fraction (LVEF) \< 40% History of cardiac arrest or cardiogenic shock Pregnancy Clinically significant peripheral arterial disease affecting the upper limbs Hepatic dysfunction (bilirubin \> 20 μmol/L or INR \> 2.0) Renal failure (eGFR \< 20 mL/min/1.73 m²) Ongoing treatment with glibenclamide or nicorandil (agents known to interfere with ischemic preconditioning mechanisms) Asthma
Where it's running
-
Mugla Training and Research Hospital
Muğla, Turkey (Türkiye) Recruiting -
Mugla Training and Research Hospital
Muğla, Turkey (Türkiye) Not yet recruiting
Study contacts
- Study coordinator: Melike Korkmaz Toker, Associate Professor
- Email: meltoker@gmail.com
- Phone: 00905054747098
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.