Diabetes MellitusNCT07151222
Role of Red Blood Cells in Cardiovascular Disease
An observational study of Diabetes Mellitus, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The risk of myocardial infarction is dependent on cardiovascular risk factors including type 2 diabetes (T2D) but underlying mechanisms are poorly understood. We identified that red blood cells (RBCs) mediate beneficial cardiovascular regulatory effects under hypoxic/ischemic conditions via signaling by nitric oxide… Read more about this study
- Who is it for?
- Ages 25 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 500 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2017to 30 Dec 2031
- Phase
- Observational
- 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 25 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Type 2 Diabetes
Who may be able to join
- Type 2 diabetes
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska Institutet
Stockholm, Swsden, 17176
Stina Smetana, Nurse, +46 725841182, stina.smetana@regionstockholm.se
About this study
Official title: The Red Blood Cell as a Mediator and Therapeutic Target in Cardiovascular Disease
The risk of myocardial infarction is dependent on cardiovascular risk factors including type 2 diabetes (T2D) but underlying mechanisms are poorly understood. We identified that red blood cells (RBCs) mediate beneficial cardiovascular regulatory effects under hypoxic/ischemic conditions via signaling by nitric oxide (NO) and soluble guanylate cyclase (sGC) in the RBCs. The RBCs become dysregulated in T2D which induces endothelial and cardiac injury. This project investigates the signaling of RBCs in cardiovascular disease and explores novel therapeutic strategies that target RBC function in myocardial infarction and T2D.
Aims To determine the
Read more
- mechanisms behind cardioprotective effect of RBCs in myocardial infarction
- signaling behind cardiovascular injury induced by RBCs in T2D
Work plan RBCs collected from patients with myocardial infarction, patients with T2D and healthy controls are investigated in bioassays including isolated hearts of ischemia/reperfusion, endothelial function and cell cultures. Molecular mechanisms behind the effects of RBCs are identified with focus on the NO-sGC pathway in the RBCs.
This project unravels the RBC as a mediator of cardiovascular disease and has the potential to identify novel therapeutic strategies by targeting RBC signaling.
Read the detailed description
The function of RBCs are investigated in functional bioassays and cell culture systems. The bioassays include isolated hearts subjected to ischemia-reperfusion and isolated arteries. the readouts are left ventricular function, infarct size and endothelial function . Comparisons are made between RBCs collected from patients with cardiovascular disease, type 2 diabetes and healthy controls. Pharmacological interventions are performed by ex vivo incubations with focus on the NO-sGC pathway.
- Conditions
- Diabetes Mellitus
- Keywords
- Red blood cells, Nitric oxide, diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetes | Patients with type 2 diabetes | |
| Type 1 diabetes | Patients with type 1 diabetes | |
| Coronary artery disease/Myocardial infarction | Patients with acute coronary syndromes | |
| Healthy controls | Age- and gender-matched healthy subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Red blood cell function defined as their ability to modulated post-ischemic recovery of left ventricular developed pressure, myocardial infarct size and endothelium-dependent relaxation.
The function of red blood cells (RBCs) are investigated in isolated heart preparations and in isolated aorta.
The heart preparations are subjected to ischemia followed by 60 min reperfusion and RBCs are administered into the coronary circulation at the onset of ischemia. Left ventricular developed pressure is recorded as readout of left ventricular function. Final infarct size is determined at the end of the reperfusion period.
Isolated arteries are co-incubated with the RBCs for 18 h. Following the incubation, the arteries are mounted in myographs for the determination of endothelium-dependent and endothelium-independent relaxations.
Measured: At 60 min of reperfusion
Secondary outcomes (1)
Red blood cell production of reactive oxygen species
Red blood cell (RBC) production of reactive oxygen species (ROS) is determined at baseline and following incubation of the RBCs with pharmacological tools that modulate different sources of ROS formation. These include nitric oxide synthase inhibitors, NADPH-oxidase inhibitors, arginase inhibitors.
Measured: At baseline and following ex vivo inhibition of ROS formation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start1 Jan 2017
- Primary completion30 Dec 2030 (estimated)
- Study completion30 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital
- Responsible party
- Principal investigator, John Pernow, Karolinska Institutet
- Investigators
- John Pernow, MD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151222
- Sponsor's protocol ID
- 2024-02534
- Status last verified
- Aug 2025
- First submitted
- 25 Feb 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pernow J, Yang J. Red blood cells: a new target to prevent cardiovascular disease? Eur Heart J. 2024 Oct 21;45(40):4249-4251. doi: 10.1093/eurheartj/ehae454. No abstract available.
PubMed 39258963
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Red Blood Cell as a Mediator and Therapeutic Target in Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT07151222
- Acronym / sponsor ID
- 2024-02534
- Conditions
- Diabetes Mellitus
- Keywords
- Red blood cells, Nitric oxide, diabetes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Karolinska University Hospital
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Dec 2030 (estimated)
- Study completion
- 30 Dec 2031 (estimated)
- First posted
- 3 Sep 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.
The risk of myocardial infarction is dependent on cardiovascular risk factors including type 2 diabetes (T2D) but underlying mechanisms are poorly understood. We identified that red blood cells (RBCs) mediate beneficial cardiovascular regulatory effects under hypoxic/ischemic conditions via signaling by nitric oxide (NO) and soluble guanylate cyclase (sGC) in the RBCs. The RBCs become dysregulated in T2D which induces endothelial and cardiac injury. This project investigates the signaling of RBCs in cardiovascular disease and explores novel therapeutic strategies that target RBC function in myocardial infarction and T2D.
Aims To determine the
- mechanisms behind cardioprotective effect of RBCs in myocardial infarction
- signaling behind cardiovascular injury induced by RBCs in T2D
Work plan RBCs collected from patients with myocardial infarction, patients with T2D and healthy controls are investigated in bioassays including isolated hearts of ischemia/reperfusion, endothelial function and cell cultures. Molecular mechanisms behind the effects of RBCs are identified with focus on the NO-sGC pathway in the RBCs.
This project unravels the RBC as a mediator of cardiovascular disease and has the potential to identify novel therapeutic strategies by targeting RBC signaling.
Detailed description
The function of RBCs are investigated in functional bioassays and cell culture systems. The bioassays include isolated hearts subjected to ischemia-reperfusion and isolated arteries. the readouts are left ventricular function, infarct size and endothelial function . Comparisons are made between RBCs collected from patients with cardiovascular disease, type 2 diabetes and healthy controls. Pharmacological interventions are performed by ex vivo incubations with focus on the NO-sGC pathway.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetes | – | –Patients with type 2 diabetes |
| Type 1 diabetes | – | –Patients with type 1 diabetes |
| Coronary artery disease/Myocardial infarction | – | –Patients with acute coronary syndromes |
| Healthy controls | – | –Age- and gender-matched healthy subjects |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Type 2 Diabetes
Key inclusion criteria (1 listed)
- Type 2 diabetes
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Red blood cell function defined as their ability to modulated post-ischemic recovery of left ventricular developed pressure, myocardial infarct size and endothelium-dependent relaxation.
Time frame: At 60 min of reperfusion
The function of red blood cells (RBCs) are investigated in isolated heart preparations and in isolated aorta. The heart preparations are subjected to ischemia followed by 60 min reperfusion and RBCs are administered into the coronary circulation at the onset of ischemia. Left ventricular developed pressure is recorded as readout of left ventricular function. Final infarct size is determined at the end of the reperfusion period. Isolated arteries are co-incubated with the RBCs for 18 h. Following the incubation, the arteries are mounted in myographs for the determination of endothelium-dependent and endothelium-independent relaxations.
1 secondary outcome
Red blood cell production of reactive oxygen species
Time frame: At baseline and following ex vivo inhibition of ROS formation.
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 3 Sep 2025.
- Results publication: PubMed 39258963Pernow J, Yang J. Red blood cells: a new target to prevent cardiovascular disease? Eur Heart J. 2024 Oct 21;45(40):4249-4251. doi: 10.1093/eurheartj/ehae454. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
John Pernow, MD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Karolinska Institutet at 1 site in Sweden.
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 1 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 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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 John Pernow, MD (+46704848361, john.pernow@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Red blood cell function defined as their ability to modulated post-ischemic recovery of left ventricular developed pressure, myocardial infarct size and endothelium-dependent relaxation. (time frame: At 60 min of reperfusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07151222, which also lists 1 linked publication.
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 3 Sep 2025.