Using brief arm cuff cycles to protect the heart during bypass surgery for people with type 2 diabetes

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

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

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 45 Years to 85 Years
• Sex: All
• Sponsor: Muğla Sıtkı Koçman University (other)
• Locations: 2 sites (Muğla and 1 other locations)
• Trial ID: NCT06977230 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Muğla and 1 other locations

• Mugla Training and Research Hospital — Muğla, Turkey (Türkiye) (NOT_YET_RECRUITING)
• Mugla Training and Research Hospital — Muğla, Turkey (Türkiye) (RECRUITING)

Study contacts

• Study coordinator: Melike Korkmaz Toker, Associate Professor

Conditions: Diabetes Mellitus, Coronary Artery Bypass, Remote Ischaemic Conditioning, High sensitive Troponin T, Diabetes mellitus Type 2, Myocardial Ischemia, Remote Ischemic Conditioning, Acute Kidney Injury