Cholesterol Lowering and Residual Risk in Diabetes, Type 1
Start Date
12/6/2022
Completion Date
7/31/2027
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.
Detailed Description
Participants will receive weekly injections of PCSK9i (evolocumab) plus daily, oral pills of atorvastatin or ezetimibe for 1 month. Participants will undergo blood draw, and optional vascular studies that include: * Glycocalyx testing (A non-invasive test where a video microscope camera is placed under the tongue to capture images of the movement of red blood cells as they travel through the micro-blood vessels) * PET/CT for vascular imaging - to assess any inflammation of blood vessels and to evaluate increased metabolism in related tissues, and * Endothelial cell collection before cholesterol reduction and 1-month after cholesterol reduction to measure any genetic changes in in the endothelial cells before and after collection Glycemic Variability (GV), the amount one's blood sugar changes throughout the day, will be analyzed from continuous glucose monitoring (CGM) data.
Eligibility Criteria
Age Range: 18 years to 89 years
Interventions
Evolocumab Cartridge
Atorvastatin Calcium Tablets
Ezetimibe Tablets
18F-FDG
Angiocatheter 20IV
J-Wire
GlycoCheck Glycocalyx Measurement Software
Conditions
Locations
New York VA Hospital
New York, New York 10010
United States
NYC Health + Hospitals/Bellevue
New York, New York 10016
United States
NYU Langone Health
New York, New York 10016
United States
Mount Sinai School of Medicine
New York, New York 10029
United States