CHOlesterol Lowering and Residual Risk in Type 2 Diabetes

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: NYU Langone Health
• Treatments: Atorvastatin; Evolocumab; Ezetimibe

Criteria

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.