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Cholesterol Lowering and Residual Risk in Diabetes, Type 1
Sponsor: NYU Langone Health
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
Evolocumab Cartridge
Injectable PCSK9 inhibitor.
Atorvastatin Calcium Tablets
HMG-CoA reductase inhibitor for oral use.
Ezetimibe Tablets
Will only be distributed to patients with statin intolerance; replacement for both Atorvastatin and Evolocumab. Inhibitor of intestinal cholesterol for oral use.
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.
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.
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.
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