CHOlesterol Lowering and Residual Risk in Type 2 Diabetes (CHORD)

  • STATUS
    Recruiting
  • End date
    Dec 21, 2023
  • participants needed
    150
  • sponsor
    NYU Langone Health
Updated on 21 March 2022
stroke
heart disease
hmg-coa reductase inhibitors
Accepts healthy volunteers

Summary

The purpose of this study is to investigate why individuals with type 2 diabetes are at increased risk for heart disease and stroke. This study will investigate risk factors for heart disease and stroke, including platelet (involved in clotting) activity, inflammation, blood vessel wall function, and genetic information (blueprints of your cells), in participants with type 2 diabetes and elevated cholesterol. This study will also include a control group - subjects with elevated cholesterol who do not have diabetes. All participants will be given cholesterol-lowering medicines (PCSK9 inhibitor and statin or ezetimibe) for 1 month with the same risk factors being measured following cholesterol reduction. This study will help understand why individuals with type 2 diabetes are at higher risk for heart disease and stroke before and even after cholesterol reduction.

Description

As part of this SFRN investigating REPAIR (non-progression of clinical events or regression of atherosclerosis) in T2D, this project will reveal mechanisms behind the platelet mediated increased cardiovascular risk in patients with T2D by focusing on the platelet transcriptome in those with clinical progression and subsequent cardiovascular events versus those without clinical progression. A prospective clinical study will investigate platelet activity and transcriptome before and after significant cholesterol reduction to better understand mechanisms of increased residual risk observed in patients with T2D, even when cholesterol is not elevated. By combining prospective studies on the platelet phenotype in humans with T2D, mechanistic mouse models of diabetes-accelerated atherosclerosis in the Fisher, Basic Project, and the human plaque and genomic data available data from the Giannarelli, Population Project, the investigators believe the research will fill an important and clinically significant gap in the understanding of how diabetes attenuates cardiovascular repair and to identify new treatment and prevention strategies.

Details
Condition Type 2 Diabetes
Treatment Statin, PCSK9 Inhibitor, Ezetimibe 10mg
Clinical Study IdentifierNCT04369664
SponsorNYU Langone Health
Last Modified on21 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects with type 2 diabetes
Age ≥ 18 & < 90
LDL-C >100mg/dl
Able and willing to provide written informed consent for the study
Control subjects without known diabetes
Age ≥ 18 & < 90
LDL-C >100mg/dl or lp(a) >50 mg/dl
Able and willing to provide written informed consent for the study

Exclusion Criteria

Subjects with type 2 diabetes
Established cardiovascular disease on antithrombotic therapy
Triglycerides >250mg/dl
Use of a PCSK9 inhibitor
HbA1c >10%
Recent infection in the past 30 days
Any hospitalization in the past 30 days
Use of Immunosuppressive therapy
Use of any antithrombotic therapy
Use of aspirin
Use of NSAID within the past 72 hours
Pregnancy
Anemia (hemoglobin < 9 g/dl) or thrombocytopenia (Platelet count <75), or thrombocytosis (Platelet count >600)
A history of severe bleeding or bleeding disorders
Chronic kidney disease (CrCl < 30ml/min)
Control subjects without known diabetes
Diabetes (type 1 or type 2)
All other exclusions are identical to the type 2 diabetes group
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