Cholesterol Lowering and Residual Risk in Diabetes, Type 1 (CHORD1)
Type 1 Diabetes
About this trial
This is an interventional other trial for Type 1 Diabetes
Eligibility Criteria
Inclusion Criteria: Participants with previous diagnosis of T1D (as defined by American Diabetes Association or judgment of physician for at least 1 year) American Diabetes Association Criteria for diagnosis of diabetes (Must meet at least 1 of the following criteria): i. FPG ≥126 mg/dL (7.0 mmol/L). Fasting is defined as no caloric intake for at least 8 hours, OR; ii. 2-h PG ≥200 mg/dL (11.1 mmol/L) during OGTT. The test should be performed using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water, OR; iii. A1C ≥6.5% (48 mmol/mol), OR; iv. In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥200 mg/dL (11.1 mmol/L), AND; History of T1D (due to autoimmune β-cell destruction, usually leading to absolute insulin deficiency, including latent autoimmune diabetes of adulthood). Autoimmune markers include islet cell autoantibodies and autoantibodies to GAD (glutamic acid decarboxylase, GAD65), insulin, the tyrosine phosphatases islet antigen 2 (IA-2) and IA-2β, and zinc transporter 8, OR; Diagnosis of T1D and confirmed by review of records by 2 separate clinical members of the study team Age ≥ 18 & < 90 LDL-C >100mg/dl Able and willing to provide written informed consent for the study Exclusion Criteria: Established cardiovascular disease on antithrombotic therapy Triglycerides >400mg/dl Use of a PCSK9 inhibitor Recent infection in the past 30 days Any hospitalization in the past 30 days Use of immunosuppressive therapy Use of any antithrombotic therapy Use of aspirin Use of NSAID within the past 72 hours Pregnancy Anemia (hemoglobin < 9 g/dl) or thrombocytopenia (platelet count <75), or thrombocytosis (platelet count >600) A history of hemorrhagic diathesis Chronic kidney disease (CrCl < 30ml/min) T2D, monogenic diabetes syndromes, or diabetes in the context of disease of the exocrine pancreas (such as pancreatitis, trauma or pancreatectomy, neoplasia, cystic fibrosis, hemochromatosis)
Sites / Locations
- New York VA HospitalRecruiting
- NYC Health + Hospitals/BellevueRecruiting
- NYU Langone HealthRecruiting
Arms of the Study
Arm 1
Experimental
4-Week LDL-Cholesterol (LDL-C)-Reduction Treatment
Treatment consists of: Evolocumab (140 mg; 2 injections, one administered at baseline visit and another self-administered 2 weeks later), and; Atorvastatin (up to 80mg dose; 1 tab per day for 30 days, starting at baseline visit post-assessment). Participants with statin intolerance will be provided with a 1-month supply of ezetimibe 10 mg to replace Evolocumab and Atorvastatin. Additional procedures: Blood draws. Optional procedures: Glycocalyx testing, PET/CT, or Endothelial Cell Collection.