Cholesterol Lowering and Residual Risk in Diabetes, Type 1

PHASE4RecruitingINTERVENTIONAL
Enrollment

125

Participants

Timeline

Start Date

December 6, 2022

Primary Completion Date

July 1, 2027

Study Completion Date

July 31, 2027

Conditions
Type 1 Diabetes
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.

Trial Locations (4)

10010

RECRUITING

New York VA Hospital, New York

10016

RECRUITING

NYC Health + Hospitals/Bellevue, New York

RECRUITING

NYU Langone Health, New York

10029

RECRUITING

Mount Sinai School of Medicine, New York

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

NYU Langone Health

OTHER