Diabetes Mellitus, Type 2 Clinical Trial
— IPE-PREVENTIONOfficial title:
The Icosapent Ethyl and Prevention of Vascular Regenerative Cell Exhaustion Study
Verified date | March 2024 |
Source | Canadian Medical and Surgical Knowledge Translation Research Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
IPE-PREVENTION is a prospective, randomized, 3-month long, open-label study. A total of 70 individuals with elevated cardio-metabolic risk and heightened triglyceride levels, and who are on stable statin therapy will be randomized (1:1) to receive either icosapent ethyl (IPE) 2g BID or standard of care. It is hypothesized that assignment to IPE will lower progenitor cell depletion as well as limit progenitor cell dysfunction. This study may offer some molecular and cellular insights into the mechanisms underlying the cardiovascular benefits of IPE therapy reported in the REDUCE-IT trial.
Status | Completed |
Enrollment | 70 |
Est. completion date | May 25, 2023 |
Est. primary completion date | May 25, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | Inclusion Criteria: 1. Women =65 years of age and men =40 years of age with established CVD (see criterion 'a' below) or =50 years of age with diabetes and one additional CV risk factor (see criterion 'b' below) 1. Those with established CVD should have =1 of the following clinical history - Documented coronary artery disease (CAD) - Prior MI - Multivessel CAD (=50% stenosis in =2 major epicardial coronary arteries) - Hospitalization for high-risk non-ST-segment elevation acute coronary syndrome - Documented cerebrovascular or carotid disease (=1 of the following) - Prior ischemic stroke - Carotid artery disease with =50% stenosis - History of carotid revascularization - Documented peripheral artery disease (=1 of the following) - Ankle-brachial index (ABI) <0.9 with symptoms of intermittent claudication - History of aorto-iliac or peripheral arterial intervention 2. Those with a history of diabetes (either type 1 or type 2 diabetes mellitus) but no CVD should also have =1 of the following: - Cigarette smoker or stopped smoking within 3 months before the baseline visit - Documented hypertension OR on antihypertensive agents - HDL-C =1.0 mmol/L for men or =1.3 mmol/L for women - High sensitivity C-reactive protein >3.0 mg/L - eGFR 30 to 60 mL/min/1.73m2 - Documented micro- or macro-albuminuria - Retinopathy - Non-proliferative retinopathy - Preproliferative or proliferative retinopathy - Maculopathy - Advanced diabetic retinopathy - History of photocoagulation - ABI <0.9 without symptoms of intermittent claudication 2. Elevated triglycerides (=1.5 mmol/L but <5.6 mmol/L) 3. On stable statin therapy for =4 weeks at the baseline visit 4. Willing to provide written informed consent and be compliant with the study requirements 5. Willing and able to follow the diet recommended by the study doctor Exclusion Criteria: 1. Participation in another clinical trial with an investigational agent =90 days prior to screening 2. Women who are of childbearing potential 3. Any condition or therapy which the study doctor thinks might pose a risk to the participant 4. Severe (New York Heart Association class IV) heart failure 5. Any life-threatening disease expected to result in death within the next 2 years 6. Diagnosis or laboratory evidence of active severe liver disease 7. HbA1c >10.0% at the baseline visit 8. SBP =200 mmHg or DBP =100 mmHg (despite being on antihypertensive therapy) 9. Planned coronary intervention or any non-cardiac major surgical procedure 10. Known familial lipoprotein lipase deficiency, apolipoprotein C-II deficiency, or familial dysbetalipoproteinemia 11. Statin intolerant or hypersensitivity to statin therapy 12. Require peritoneal dialysis or hemodialysis 13. eGFR <30 mL/min/1.73m2 14. History of atrial fibrillation 15. History of major bleeding event(s) 16. Documented history of pancreatitis 17. Malabsorption syndrome and/or chronic diarrhea 18. Known acquired immunodeficiency syndrome 19. Unexplained elevated creatine kinase concentration >5 × the upper limits of normal or elevation due to known muscle disease 20. Use of niacin, fibrates, omega-3 fatty acids, dietary supplements containing omega-3 fatty acids, bile acid sequestrants or PCSK9 inhibitors 21. Known hypersensitivity to fish and/or shellfish, or ingredients of IPE 22. Inability to swallow IPE capsules whole 23. Drug or alcohol abuse within the past 6 months, and inability/unwillingness to abstain from drug abuse and excessive alcohol consumption during the study 24. Mental/psychological concerns or any other reason to expect difficulty in complying with the study requirements or understanding the goal and potential risks of being a part of the study |
Country | Name | City | State |
---|---|---|---|
Canada | The Oshawa Clinic | Oshawa | Ontario |
Canada | Diagnostic Assessment Centre | Scarborough | Ontario |
Canada | Langstaff Medical Clinic | Vaughan | Ontario |
Lead Sponsor | Collaborator |
---|---|
Canadian Medical and Surgical Knowledge Translation Research Group | HLS Therapeutics, Inc, Unity Health Toronto, Western University, Canada |
Canada,
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in the ratio of ALDHhiSSCmid pro-inflammatory:anti-inflammatory monocyte precursor cells in individuals treated with IPE compared to SOC for 3-months. | Baseline - 3 months post-randomization | ||
Other | Change in the mean frequency of ALDHhiSSChi cells in individuals treated with IPE compared to SOC for 3-months. | Baseline - 3 months post-randomization | ||
Other | Changes in the concentration of serum oxidative stress markers from baseline to the 3-month visit in individuals treated with IPE compared to SOC | Baseline - 3 months post-randomization | ||
Other | Changes in the concentration of serum inflammatory markers from baseline to the 3-month visit in individuals treated with IPE compared to SOC | Baseline - 3 months post-randomization | ||
Primary | Change in the frequency of ALDHhiSSClowCD133+ cells in individuals treated with IPE compared to SOC for 3 months | Baseline - 3 months post-randomization |
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