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

Recruiting in Palo Alto (17 mi)

Overseen byJeffrey Berger, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: NYU Langone Health

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Inclusion Criteria

You must be between 18 and 90 years old.

Your LDL cholesterol level is higher than 100mg/dl.

You can and want to sign a paper saying you agree to be in the study.

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Treatment Details

Interventions

Ezetimibe 10mg (Cholesterol Absorption Inhibitor)
PCSK9 inhibitor (PCSK9 Inhibitor)
Statin (HMG-CoA Reductase Inhibitor)

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Type 2 Diabetes groupExperimental Treatment3 Interventions

All participants with type 2 diabetes will be given cholesterol-lowering medicine (evolocumab (PCSK9 inhibitor) plus atorvastatin (statin) or ezetimibe (zetia)) for 1 month with the same risk factors being measured following cholesterol reduction. They will be asked to undergo blood draw, to receive study medication, and to undergo additional optional vascular health testing including endothelial cell harvesting and glycocalyx (tongue probe).

Group II: Control groupExperimental Treatment3 Interventions

The participants in the control group are subjects with elevated cholesterol who do not have diabetes. All participants will be given cholesterol-lowering medicines (evolocumab (PCSK9 inhibitor) plus atorvastatin (statin) or ezetimibe (zetia)) for 1 month with the same risk factors being measured following cholesterol reduction. They will be asked to undergo blood draw, to receive study medication, and to undergo additional optional vascular health testing including endothelial cell harvesting and glycocalyx (tongue probe).