Diabetes MellitusNCT06977230
Remote Ischemic Preconditioning in Type 2 Diabetic Patients Undergoing CABG
A study testing Remote Ischemic Preconditioning in people with Diabetes Mellitus and Coronary Artery Bypass, run by Muğla Sıtkı Koçman University at 2 sites in Turkey (Türkiye).
Trial summary
This randomized, double-blind, prospective clinical trial aims to investigate the effect of remote ischemic preconditioning (RIPC) on myocardial protection in patients with type 2 diabetes mellitus undergoing elective coronary artery bypass graft (CABG) surgery. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Diabetes Mellitus, Coronary Artery Bypass, Remote Ischaemic Conditioning
- What is being tested?
- Remote Ischemic Preconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 26 May 2025to 15 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Not yet recruiting
Mugla Training and Research Hospital
Muğla, 48000
Melike Korkmaz Toker, 00905054747098, meltoker@gmail.com
- Recruiting
Mugla Training and Research Hospital
Muğla
Melike Korkmaz Toker, meltoker@gmail.com
About this study
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
This randomized, double-blind, prospective clinical trial aims to investigate the effect of remote ischemic preconditioning (RIPC) on myocardial protection in patients with type 2 diabetes mellitus undergoing elective coronary artery bypass graft (CABG) surgery. Perioperative myocardial injury remains a significant concern during CABG, particularly in high-risk patients such as those with diabetes. RIPC is a low-cost, non-invasive intervention that may reduce myocardial damage by enhancing ischemic tolerance through intermittent limb ischemia.
Sixty patients aged 40-85 years with type 2 diabetes scheduled for isolated CABG will be randomized to either receive RIPC or standard care. RIPC will be applied through five cycles of upper limb cuff inflation and deflation prior to sternotomy. High-sensitivity troponin T levels will be measured at 24, 48, and 72 hours postoperatively to assess myocardial injury. Secondary outcomes include acute kidney injury (KDIGO classification), maximum vasoactive-inotropic score (VIS) during the first 72 postoperative hours, ICU and hospital length of stay. This study will provide insight into the cardioprotective role of RIPC in diabetic patients undergoing cardiac surgery.
- Being tested
- Remote Ischemic Preconditioning
- Keywords
- High sensitive Troponin T, Diabetes mellitus Type 2, Coronary Artery Bypass, Myocardial Ischemia, Remote Ischemic Conditioning, Acute Kidney Injury, Cardioprotection
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Myocardial Ischemia, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Ischemic PreconditioningProcedure or surgery
Remote ischemic preconditioning (RIPC) will be performed after anesthesia induction and before surgical incision. A standard blood pressure cuff will be placed on the upper limb (without arterial cannulation), inflated to 200 mmHg for 5 minutes, and then deflated for 5 minutes. This cycle will be repeated five times prior to sternotomy. The procedure will be carried out under general anesthesia, ensuring patient blinding. No pharmacological agents are involved in this intervention
| Study group | Role | What they receive |
|---|---|---|
| Remote Ischemic Preconditioning Group | Active comparator | Patients randomized to this group will receive remote ischemic preconditioning (RIPC) prior to sternotomy. RIPC will be performed by inflating a blood pressure cuff on the upper limb to 200 mmHg for 5 minutes, followed by 5 minutes of deflation. This cycle will be repeated 5 times before the start of cardiopulmonary bypass.Assigned Intervention: Remote Ischemic Preconditioning Receives: Procedure: Remote Ischemic Preconditioning |
| Control Group | No intervention | Patients in the control group will undergo standard anesthetic and surgical care without the application of remote ischemic preconditioning. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative 24-hour high-sensitivity Troponin T level
Myocardial injury will be assessed by measuring high-sensitivity cardiac Troponin T (hs-TnT) levels at 24 hours after coronary artery bypass graft (CABG) surgery. Blood samples will be collected at the 24th postoperative hour and analyzed using a standardized high-sensitivity Troponin T assay (reference range: 0-14 ng/L). The primary endpoint will be the mean hs-TnT concentration in each group.
Measured: 24 hours after surgery
Secondary outcomes (5)
Incidence and severity of acute kidney injury
Measured: Within 72 hours postoperatively
Postoperative 48-hour high-sensitivity Troponin T level
Myocardial injury will be assessed by measuring high-sensitivity cardiac Troponin T (hs-TnT) levels at 48 hours after coronary artery bypass graft (CABG) surgery. Blood samples will be collected at the 48th postoperative hour and analyzed using a standardized high-sensitivity Troponin T assay (reference range: 0-14 ng/L). The primary endpoint will be the mean hs-TnT concentration in each group.
Measured: 48 hours after surgery
Postoperative 72-hour high-sensitivity Troponin T level
Myocardial injury will be assessed by measuring high-sensitivity cardiac Troponin T (hs-TnT) levels at 72 hours after coronary artery bypass graft (CABG) surgery. Blood samples will be collected at the 72th postoperative hour and analyzed using a standardized high-sensitivity Troponin T assay (reference range: 0-14 ng/L). The primary endpoint will be the mean hs-TnT concentration in each group.
Measured: 72 hours after surgery
Maximum vasoactive-inotropic score (VIS) in the first 72 hours postoperatively
Measured: 0-72 hours after surgery
Length of ICU and hospital stay
Measured: From ICU admission to ICU discharge and from hospital admission to hospital discharge, assessed up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start26 May 2025
- Primary completion30 Jul 2025 (estimated)
- Study completion15 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melike Korkmaz Toker, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977230
- Sponsor's protocol ID
- RIPC-T2DM-CABG-2025
- Status last verified
- Jun 2025
- First submitted
- 7 May 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) may not be shared due to institutional policies and ethical considerations regarding patient confidentiality. The study protocol does not include provisions for public data sharing, and participants dmay not provide consent for external access to their personal health data.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06977230
- Acronym / sponsor ID
- RIPC-T2DM-CABG-2025
- Keywords
- High sensitive Troponin T, Diabetes mellitus Type 2, Coronary Artery Bypass, Myocardial Ischemia, Remote Ischemic Conditioning, Acute Kidney Injury, Cardioprotection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 26 May 2025 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, double-blind, prospective clinical trial aims to investigate the effect of remote ischemic preconditioning (RIPC) on myocardial protection in patients with type 2 diabetes mellitus undergoing elective coronary artery bypass graft (CABG) surgery. Perioperative myocardial injury remains a significant concern during CABG, particularly in high-risk patients such as those with diabetes. RIPC is a low-cost, non-invasive intervention that may reduce myocardial damage by enhancing ischemic tolerance through intermittent limb ischemia.
Sixty patients aged 40-85 years with type 2 diabetes scheduled for isolated CABG will be randomized to either receive RIPC or standard care. RIPC will be applied through five cycles of upper limb cuff inflation and deflation prior to sternotomy. High-sensitivity troponin T levels will be measured at 24, 48, and 72 hours postoperatively to assess myocardial injury. Secondary outcomes include acute kidney injury (KDIGO classification), maximum vasoactive-inotropic score (VIS) during the first 72 postoperative hours, ICU and hospital length of stay. This study will provide insight into the cardioprotective role of RIPC in diabetic patients undergoing cardiac surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote Ischemic Preconditioning Group | Active comparator | Procedure: Remote Ischemic PreconditioningPatients randomized to this group will receive remote ischemic preconditioning (RIPC) prior to sternotomy. RIPC will be performed by inflating a blood pressure cuff on the upper limb to 200 mmHg for 5 minutes, followed by 5 minutes of deflation. This cycle will be repeated 5 times before the start of cardiopulmonary bypass.Assigned Intervention: Remote Ischemic Preconditioning |
| Control Group | No intervention | –Patients in the control group will undergo standard anesthetic and surgical care without the application of remote ischemic preconditioning. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Ischemic PreconditioningRemote ischemic preconditioning (RIPC) will be performed after anesthesia induction and before surgical incision. A standard blood pressure cuff will be placed on the upper limb (without arterial cannulation), inflated to 200 mmHg for 5 minutes, and then deflated for 5 minutes. This cycle will be repeated five times prior to sternotomy. The procedure will be carried out under general anesthesia, ensuring patient blinding. No pharmacological agents are involved in this intervention | Procedure or surgery | Remote Ischemic Preconditioning Group |
Primary outcome
Postoperative 24-hour high-sensitivity Troponin T level
Time frame: 24 hours after surgery
Myocardial injury will be assessed by measuring high-sensitivity cardiac Troponin T (hs-TnT) levels at 24 hours after coronary artery bypass graft (CABG) surgery. Blood samples will be collected at the 24th postoperative hour and analyzed using a standardized high-sensitivity Troponin T assay (reference range: 0-14 ng/L). The primary endpoint will be the mean hs-TnT concentration in each group.
5 secondary outcomes
Incidence and severity of acute kidney injury
Time frame: Within 72 hours postoperatively
Postoperative 48-hour high-sensitivity Troponin T level
Time frame: 48 hours after surgery
Postoperative 72-hour high-sensitivity Troponin T level
Time frame: 72 hours after surgery
Maximum vasoactive-inotropic score (VIS) in the first 72 hours postoperatively
Time frame: 0-72 hours after surgery
Length of ICU and hospital stay
Time frame: From ICU admission to ICU discharge and from hospital admission to hospital discharge, assessed up to 60 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) may not be shared due to institutional policies and ethical considerations regarding patient confidentiality. The study protocol does not include provisions for public data sharing, and participants dmay not provide consent for external access to their personal health data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Ischemic Preconditioning in people with Diabetes Mellitus and Coronary Artery Bypass, run by Muğla Sıtkı Koçman University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melike Korkmaz Toker, Associate Professor (00905054747098, meltoker@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative 24-hour high-sensitivity Troponin T level (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.