CHORD1 CHOlesterol Lowering and Residual Risk in Diabetes Type 1

Brief description of study

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. 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 includes: - 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. Participants will be enrolled from NYU Langone Health, including the Faculty Group Practice, (e.g. NYU Center for the Prevention of CVD, Division of Endocrinology, and Diabetes Clinic at Winthrop) as well as Bellevue Hospital. Additionally, we will work with collaborators at Icahn School of Medicine at Mount Sinai (ISMMS).


Clinical Study Identifier: s22-01095
ClinicalTrials.gov Identifier: NCT05641753
Principal Investigator: Ira J Goldberg.
Other Investigators: Chiara Giannarelli, Jeffrey S Berger, Michael Seth Garshick.


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