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RECRUITING
NCT05641753
PHASE4

Cholesterol Lowering and Residual Risk in Diabetes, Type 1

Sponsor: NYU Langone Health

View on ClinicalTrials.gov

Summary

This is a prospective, interventional, cohort study, meaning that researchers will follow and observe a group of enrolled study participants over a period of time (one to two months) to gather information and record any developments of the outcomes in question. This study will recruit 125 participants with Type 1 Diabetes (T1D) to: 1. Analyze the effect of reducing the cholesterol levels in the blood on platelet function. (Platelets are small cells in the blood which help form blood clots to slow or stop bleeding and to help wounds heal 2. Analyze the effect of reducing the cholesterol levels in the blood on While Blood Cell (WBC) gene expression, (White Blood Cells are part of the body's immune system which help the body fight infection and other diseases) and 3. Analyze the effect of reducing the cholesterol levels in the blood on vascular or blood vessel function.

Official title: CHORD1 - CHOlesterol Lowering and Residual Risk in Diabetes, Type 1

Key Details

Gender

All

Age Range

18 Years - 89 Years

Study Type

INTERVENTIONAL

Enrollment

125

Start Date

2022-12-06

Completion Date

2027-07-31

Last Updated

2025-12-29

Healthy Volunteers

No

Conditions

Interventions

DRUG

Evolocumab Cartridge

Injectable PCSK9 inhibitor.

DRUG

Atorvastatin Calcium Tablets

HMG-CoA reductase inhibitor for oral use.

DRUG

Ezetimibe Tablets

Will only be distributed to patients with statin intolerance; replacement for both Atorvastatin and Evolocumab. Inhibitor of intestinal cholesterol for oral use.

DRUG

18F-FDG

Optional procedure. Positron emission tomography (PET) and computed tomography (CT) imaging to assess vascular inflammation and related anatomy requires injection of the PET tracer 18F-FDG. 18F-FDG is an FDA-approved analogue of sugar, routinely used to evaluate elevated metabolism in tissues, including increased metabolism due to inflammatory cells. A standard dose of 7.0 mSv will be administered.

DEVICE

Angiocatheter 20IV

Optional procedure (endothelial cell harvesting). An angiocatheter ≤ 21 gauge will be inserted into a peripheral vein on the upper extremity using aseptic technique. A 0.018in. diameter J-shaped wire (Arrow, Reading, PA) will be then advanced into the angiocatheter, to a distance of 4cm beyond the end of the angiocatheter.

DEVICE

J-Wire

Optional procedure (endothelial cell harvesting). Either a 0.021in. diameter J-shaped wire (Daig, Minnetonka, MN) or a 0.018in. diameter J-shaped wire (Arrow, Reading, PA) will be used.

DEVICE

GlycoCheck Glycocalyx Measurement Software

Optional procedure (assessment of vascular function). Video microscope developed by GlycoCheck.

Locations (4)

New York VA Hospital

New York, New York, United States

NYC Health + Hospitals/Bellevue

New York, New York, United States

NYU Langone Health

New York, New York, United States

Mount Sinai School of Medicine

New York, New York, United States